Dec 2008

Introduction:

Every year, approximately 200,000 people undergo elective total hip and knee replacement surgery in the UK 1. There is limited available literature on the incidence of post-operative urinary retention and even less regarding the onset of subsequent renal failure which, besides posing immediate medical problems, necessitates treatment and can significantly prolong recovery – all of which have personal and financial implications for both patient and healthcare trust.

Summary of Current Literature:

Surprisingly little research is available which offers data on the association on the incidence of, risk factors for, and associations with urinary retention for patients undergoing elective total hip or knee replacement surgery. The following table summarises seven studies conducted between 1980 and 2007:

 
Analysing the available literature, the following conclusions can be made.

1. Males are more likely than females to develop urinary retention.
2. Risk factors include a history of urinary retention, the use of epidural analgesia and patient-controlled analgesia (PCA).
3. Retention rates varied between 10% and 38.1% (mean 19.6%).
4. Deep sepsis rates varied between 0.93% and 2.1% in the total post-operative group, rising to 6.2% in those developing urinary retention.

Objectives:

This study aims to develop a policy of pre-operative catheterisation, anaesthetic technique and post-operative analgesia in patients undergoing elective total hip and knee replacement surgery that will:

1. Minimize the incidence of urinary retention.
2. Minimize the incidence of subsequent complications.
3. Hasten patient recovery and discharge.

Methods:

A prospective study was conducted between February and April 2008 in the operating theatres and on the Orthopaedic wards at Bedford Hospital, a district general hospital in Bedfordshire, UK. Data was collected that would enable the following questions to be addressed:

1. Are these patients catheterised pre-operatively?
2. Of those who are not, how many develop urinary retention?
3. Is any particular anaesthetic technique associated with an increased incidence of retention?
4. Is antibiotic prophylaxis administered for catheterisation?
5. How frequently does renal failure arise in those patients who develop urinary retention?
6. Can a protocol be created which might reduce the incidence of retention?
7. How effective and efficient would this be?

54 patients undergoing elective total hip and knee replacements were recruited into the study. Of these, 4 were catheterised pre-operatively and hence were excluded (n = 50).

Data Collection:

The primary source of data collection was from patients’ notes and anaesthetic charts, assessed pre- and post-operatively. Data was gathered in the following areas:

• Demographics – Name, Age, Sex
• ASA Classification – 1 to 4
• History of Renal disease
• History of Urological disease
• Pre-operative Creatinine
• Nature & Date of Operation
• Type of Anaesthetic Technique employed
• Onset of post-operative Urinary Retention necessitating catheterization
• Duration of Epidural Analgesia (if applicable)
• Administration of Antibiotic Prophylaxis for catheterization
• Progress from urinary retention to Renal Failure

Results:

As mentioned, 4 of the original 54 patients were excluded from the study as they had already been catheterised pre-operatively. All were female, 75% of whom were over the age of 80; it appears that the main indication for pre-operatively catheterisation was existing urinary incontinence.

There was a female preponderance amongst the sample population, with females outnumbering males by a ratio of 3 to 2. In terms of the sample population’s co-morbidities and anaesthetic risk, the majority of patients were classified as ASA 2 (60%) by the assessing anaesthetist, with ASA 3 patients (26%) outnumbering ASA 1 patients (14%) by a ratio of approximately 2 to 1 in the remainder. Over the period covered, knee replacements (70%) outnumbered hip replacements (30%) by a ratio of 7 to 3.

A range of anaesthetic techniques were employed, including:

• Combined Spinal Epidural (CSE)
• Spinal Anaesthetic (Spinal)
• General Anaesthetic + Epidural (GA + Epidural)
• General + Spinal Anaesthetic (GA + Spinal)
• General Anaesthetic + Lumbar Plexus Block (GA + LPB)
• General Anaesthetic + Femoral Nerve Block (GA + FNB)
• General Anaesthetic +/- Patient Controlled Analgesia (GA + PCA)

Spinal anaesthetics appeared to be most commonly employed, either alone or in conjunction with a general anaesthetic. GAs in combination with a nerve block was also often used, followed by CSEs.

In total, there were a total of 5 cases of post-operative urinary retention, all of which necessitated catheterisation. This results in an incidence rate of 10% across elective total hip and knee replacements. Of these anaesthetic techniques, spinal anaesthesia was associated with the highest risk of post-operative urinary retention (22.2%), followed by GAs (20%), CSEs (14.3%) and GA + FNBs (14.3%). No cases were reported for patients who underwent GA + Spinals (n = 13), GA + LPBs (n = 8) or GA + Epidurals (n = 1).

Of those patients who had undergone epidural anaesthesia, whether in combination either with a GA or a spinal, no documentation was found regarding the duration for which they had been active in 25% of cases. In the remainder, the epidural had been functional for less than 24 hours in 50% of cases.

All five patients who developed post-operative urinary retention were male; three of whom were below the age of 80. Only three of these patients received the recommended antibiotic prophylaxis on catheterisation (60%), and on following up their subsequent inpatient progress and serum creatinine, it appeared the same number progressed to renal failure (60%).

Analysis:

Two factors were identified in this study which may have predisposed these five patients into developing post-operative urinary retention. The first is a history of renal disease – 4% of the total sample had such a history (n = 2) and both went on to develop retention. The second is a currently elevated serum creatinine – 6% of the total sample had this at the time of surgery (n = 3), and of these, two went on the develop retention. The remaining patient who developed retention had neither of these risk factors.

The table below compares the results found in this study with those described in existing literature, namely the aforementioned publications. As can be seen, the post-operative urinary retention rate was on the lower extreme of that noted in the literature; only the studies by Waterhouse et al.3 and Lingaraj et al.7 demonstrated similar rates.

 This study concurred with the existing opinion that males have a higher incidence of retention, but the study population was insufficient to draw any specific conclusions regarding the influence of epidural anaesthesia on post-operative urinary retention. It was noted however, that in half of the cases for which data was available, the epidural was functional for less than 24 hours – one might argue that the risk/benefit ratio of epidural anaesthesia would cause it to be a relative contraindication if only employed for relatively short durations, particularly if the patient is admitted to a ward on which nursing staff are unfamiliar with its care.

Conclusions:

Existing literature fails to comment upon the impact of the aforementioned risk factors for retention highlighted in this study, namely a history of renal disease and a current elevated serum creatinine. However, these two factors in conjunction with the increased incidence in males allows for the creation of a system by which patients who are at high risk of developing post-operative urinary retention may be successfully identified and catheterised pre-operatively, hence preventing the problem from arising.

If a protocol had been established in which males with either of these two factors were catheterised pre-operatively, 5 patients from the sample population of 50 would have qualified; this includes 4 of the 5 patients who developed urinary retention post-operatively. In addition, only 1 patient who did not develop urinary retention post-operatively would have met these criteria and been unnecessarily catheterised pre-operatively. These figures are demonstrated in the graph below.

On the basis of these findings, one can deduce that a protocol indicating pre-operative catheterisation in males with either a history of renal disease and a current elevated serum creatinine undergoing total hip and knee replacement surgery would have a profound impact on the incidence of post-operative urinary retention, essentially reducing it by 80%. Unnecessary catheterisations as a result of this protocol would be minimal, affecting only 2% of patients.

Although this study has obvious limitations in terms of its size and its single-centred nature, findings were comparable to existing literature and are likely to be representative of incidence rates on a national, if not international basis. Further research, ideally with a larger population spread across multiple centres would allow for more accurate data to be collected, which in turn would allow for a more effective and efficient protocol to be developed.

 
References:

1. Arthritis Research Campaign; www.arc.org.uk

2. Wroblewski BM, del Sel HJ. Urethral instrumentation and deep sepsis in total hip replacement. Clinical Orthopaedic and Related Research. 1980 Jan-Feb; (146): 209-12

3. Waterhouse N, Beaumont AR, Murray K, Staniforth P, Stone MH. Urinary Retention after Total Hip Replacement. A Prospective Study. Journal of Bone and Joint Surgery, British Volume. 1987 Jan; 69 (1): 64-6

4. O’Riordan JA, Hopkins PM, Ravenscroft A, Stevens JD. Patient controlled analgesia and urinary retention following lower limb joint replacement: prospective audit and logistic regression analysis. European Journal of Anaesthesiology. 2000 Jul; 17 (7): 431-5

5. Kumar P, Mannan K, Chowdhury AM, Kong KC, Pati J. Urinary retention following arthroplasty. Urology, 2005 Sep; 66(3); Supp I: 22

6. Cronin JJ, Shannon FJ, Bale E, Quinlan W. Prediction of post-operative urinary retention following hip and knee arthroplasty in a male population. European Journal of Orthopaedic Surgery and Traumatology. 2007 Jan; (17): 47-50

7. Kumar P, Mannan K, Chowdhury AM, Kong KC, Pati J. Urinary retention and the role of indwelling catheterization following total knee arthroplasty. International Brazilian Journal of Urology 2006 Jan-Feb; (32): 1

8. Lingaraj K, Ruben M, Chan YH, De Das S. Identification of risk factors for urinary retention following total knee arthroplasty: a Singapore hospital experience. Singapore Medical Journal. 2007 Mar; 48 (3): 213-6

Septic shock still remains the one of the leading causes of death in hospital patients. Barely more than 50% of the patients with severe sepsis survive their hospital admission. This unacceptable high mortality can only be reduced if there is greater awareness and understanding of the condition .and the knowledge of most effective treatment measures available. Unplanned admissions to the Intensive Care Unit (ICU) and potentially preventable deaths on wards are associated with a failure to institute early preventive conditions. Greater than 40% of the intensive Care Unit admissions are potentially preventable with improved ward care.

Survival of patients with Septic shock appears to be better if shock develops while the patient is in Intensive Care Unit rather than on general ward despite greater severity of illness in the intensive care group [1].This suggests that the closer observation and earlier treatment can influence the outcome of sepsis.

INCIDENCE:

Septic shock is an increasingly common problem. The incidence of sepsis is increasing year by year. The reasons for this increase are that the people are living longer and this aged population are the most vulnerable to sepsis. We are using advanced technology to sustain life and there has been a rise in the number of immunocompromised patients due to aggressive cancer therapy and the increased prevalence of HIV. The widespread use of broad spectrum antibiotics has increased the rate of both antibiotic resistance and nosocomial infections.

A prospective, multicentre, observational study, recently conducted to evaluate the epidemiology of Sepsis and other characteristics of Intensive Care Unit patients in European countries (called the SOAP study) was endorsed by the European Society of Intensive Care Medicine [2]. This observational study showed a marked difference in the frequency of sepsis between countries, and higher frequencies of sepsis were mirrored by higher mortality rates. (Fig.1)

Fig 1: Incidence of Sepsis in European Countries

There was a direct relationship between the number of organs failing and the Intensive Care Unit mortality. Patients with no organ dysfunction on admission had mortality rates of 6% whereas those with four or more organ failures had mortality rates of 65 %. [2] (Fig. 2)

Fig 2: The SOAP study

As compared to the incidence of other pathologies in Europe the incidence of severe sepsis is higher (32%) [2] (Fig 3)

Fig 3: Incidence of different pathologies in Europe

In septic patients, older age, positive fluid balance, co morbid diseases on admission; cancer and cirrhosis are the most important variables of mortality.

DEFINITIONS

Sepsis is defined as an infection that triggers a particular Systemic Inflammatory Response Syndrome (SIRS). This is characterised by body temperature outside 36oC - 38oC, HR >90 beats/min, respiratory rate >20/min, WBC count >12,000/mm3 or < 4,000/mm3. (Fig 4)

Fig 4: Definitions

There are three recognised stages in the hierarchy of the inflammatory response, with progressively increased risk of organ failure and death. Patients with infections plus two or more elements of the SIRS meet the criteria for sepsis. Those who have end organ failure are considered as having severe sepsis; and those who have refractory hypotension along with the above said criteria are consider to be in septic shock (Fig. 5)

Fig 5:  Definitions

PATHOPHYSIOLOGY:

Sepsis is a complex condition starting from an infective stimulus and resulting in an exaggerated immune response. The inflammatory response that was initiated to fight the infection ultimately leads to damage of various organs thorough out the body.

During the onset of sepsis, the inflammatory system becomes hyperactive, involving both cellular and humoral defence mechanisms Endothelial and epithelial cells, as well as neutrophils, macrophages and lymphocytes, produce powerful pro-inflammatory mediators, especially tumour necrosis factor- (TNF-), interleukin (IL)-6, IL-1 and IL-8. Simultaneously, robust production of acute-phase proteins, such as C-reactive protein, occurs and humoral defence mechanisms such as the complement system are activated, resulting in production of pro-inflammatory mediators, including C5a, the complement split product. C5a ultimately enhances cytokine and chemokine production. Furthermore, the coagulation system becomes activated through various mechanisms, often resulting in disseminated intravascular coagulopathy.

The hallmarks of the sepsis are excessive inflammation, excessive coagulation and suppression of fibrinolysis. In addition endogenous Activated Protein C which modulates coagulation, controls inflammation and supports fibrinolysis is also decreased. There is considerable variability in response which is almost certainly to a large degree genetically determined. Those with a tendency to produce excessive cytokines and TNF will have a greater inflammatory response. Simultaneously, the initial vascular damage results in neutrophil activation, neutrophil-endothelial cell adhesion, and further elaboration of inflammatory cytokines. In tissues already prone to dysfunctional oxygen uptake and metabolism, this vascular injury promotes further tissue hypoxia through regional hypo perfusion. This uncontrolled cascade of inflammation and coagulation fuels the progression of sepsis, resulting in tissue hypoxia and ischemia with resultant organ dysfunction and death.

DIAGNOSIS:

Diagnosis of sepsis is not easy. Making an early, accurate diagnosis of septic shock is a key to increasing survival rates. The signs and symptoms of severe sepsis may be subtle. Although the components of SIRS are non specific, the combination of suspected infection and the presence of SIRS may help alert the clinician to a possible diagnosis of sepsis. Although hypotension is another clinical sign that may signal the onset of septic shock, patient may present with sever sepsis and clinically significant global tissue hypoxia in its absence. Metabolic marker such as serum lactate, arterial base deficit may help to identify the severe cases. A single lactate measurement of 4mmol/l or more at initial presentation is associated with an increased rate of mortality [3]. There may well be signs of altered mentation and   abnormalities of renal and liver function test, as well as coagulation abnormalities. At least two blood cultures and cultures of other sites as indicated before commencement of antibiotic therapy. Diagnostic studies such as Ultra sound and CT scan should be performed promptly.

D dimmers are grossly elevated in sepsis. Levels of Protein C are lowered which has therapeutic implications. The potential role of biomarkers for diagnosis of infection in patients presenting with severe sepsis remains undefined. Perhaps the most common considerations as diagnostic biomarkers for sepsis have been C-reactive protein and procalcitonin. Despite initial enthusiasm for their potential diagnostic strengths,[4] they have more recently been related to the growing heap of biomarkers that have failed to accurately differentiate sepsis from similar critical illnesses.

The most exciting development in the last 2 years is the recognition of "soluble triggering receptor expressed on myeloid cells-1" (sTREM-1) as a potential biomarker for sepsis. [5] For this marker, a level greater than 60 ng/mL was more accurate than any other clinical and laboratory findings indicating infection

TREATMENT:

The development of new treatment modalities has resulted in a spate of treatment algorithms, often promulgated by medical societies and healthcare improvement organizations. As these modalities have rolled out, increasing levels of evidence have emerged to support or refute their utility in treating patients with sepsis. One of the greatest endeavours to date is the Surviving Sepsis Campaign (SSC) [6] that was originally launched in 2002 with the stated goal to reduce mortality by 25%. The primary method to achieve this goal was the development of evidence-based sepsis care guidelines that were published in 2004. [6] and recently revised in 2008.

The Institute for Healthcare Improvement (IHI) has highlighted sepsis as an area of focus and has identified several deficiencies that may cause suboptimal care of patients with severe sepsis. These deficiencies include inconsistency in the early diagnosis of severe sepsis and septic shock, frequent inadequate volume resuscitation without defined endpoints, late or inadequate use of antibiotics, frequent failure to support the cardiac output when depressed, frequent failure to control hyperglycemias adequately, frequent failure to use low tidal volumes and pressures in acute lung injury, and frequent failure to treat adrenal inadequacy in refractory shock.

The management of patient with sepsis is influenced more by appropriate treatment with antibiotics and fluids than by specific intensive care. Therefore early intervention should never be delayed pending admission to the intensive care unit. The early and aggressive treatment of septic shock has been well documented in the survival sepsis campaign which is based on the best current practice.

The cornerstones of treatment are infection control, haemodynamic stabilization, and modulation of the septic response.

1. Infection Control:

Infection control is vital if the patient is to have any chance of survival. Appropriate broad-spectrum antibiotics must be given within the first hour of recognition of sepsis after obtaining various cultures. Evidence clearly shows that delay or inadequate antibiotic treatment results in poorer outcome. For every hour lost mortality climbs by 9%. [7] 

Initial empirical anti-infective therapy should include one or more drugs that have activity against all likely pathogens (bacterial and/or fungal) and that penetrate in adequate concentrations into the presumed source of sepsis[8] antimicrobial regimen be reassessed daily to optimize activity, to prevent the development of resistance, to reduce toxicity, and to reduce costs

A focus of infection must be sought for and if discovered dealt with immediately. The patient should be evaluated for a focused infection amenable to source control measures including abscess drainage or tissue debridement. One must weigh up the benefits and risks of the particular procedure chosen. If intravascular devices are a potential source, they must be promptly removed after establishing other vascular access. When source control is required, the effective intervention associated with the least physiologic insult be employed (e.g., percutaneous rather than surgical drainage of an abscess)

2. Haemodynamic Stabilization:

In septic shock there is extensive cardiovascular derangement. Hypotension is caused by myocardial depression, pathological vasodilatation and extravasation of circulating volume due to widespread capillary leak. The initial resuscitative effort is to attempt to correct the absolute and relative hypovolemia by refilling the vascular tree. There is no evidence to support one type of fluid crystalloid or colloid is superior to the other. There is good evidence that early gold directed aggressive volume resuscitation improves outcome of sepsis[9] During the first 6 hours of resuscitation the goals of initial resuscitation are a Central venous pressure of  8-12 mm Hg, Mean arterial pressure (MAP) ≥ 65 mmHg, Urine output ≥ 0.5 mL • kg-1 • hr and a  central venous (superior vena cava) or mixed venous oxygen saturation ≥ 70% or ≥ 65%, respectively The Rivers study clearly shows a reduction in  hospital mortality, 28 day mortality as well as 60 day mortality attributed to the Early Goal Directed Therapy (EGDT) [10]. Early goal-directed resuscitation has been shown to improve survival for emergency department patients presenting with septic shock in a randomized, controlled, single-centre study.[11] Resuscitation directed toward the previously mentioned goals for the initial 6-hr period of the resuscitation was able to reduce in hospital, 28-days as well as 60 days mortality rate (Fig. 6).

Fig 6: Results of Early Goal Directed Therapy (EGDT)

If Scvo2 or SVo2 of 70% or 65%, respectively, is not achieved with fluid resuscitation to the central venous pressure target, then transfusion of packed red blood cells to achieve a hematocrit of ≥ 30% and/or administration of a dobutamine infusion (up to a maximum of 20 µg • kg-1 • min-1) be used to achieve this goal.

It is important to remember that vasopressors should be utilized not only when fluids fail to reverse hypotension, but also during resuscitation to maintain minimally adequate blood pressure. Traditionally, the use of noradrenalin in patients with shock has been restricted by the fear of excessive vasoconstriction that may result in end-organ hypo perfusion. In the past it was usually given only when other vasopressin agents failed, and thus such patients would be predicted to have a poor outcome. Recent studies indicate that the fear of deleterious effect was unwarranted and that noradrenalin may have a role as a first-line vasopressor agent in patients with septic shock.

Vasopressin should be considered in refractory shock despite high dose conventional vasopressors. Vasopressin is an endogenously produced hormone that is deficient in many patients with septic shock. Exogenously administered vasopressin in physiologic replacement doses may act synergistically with other vasopressor agents, and has been associated with early withdrawal of catecholamine. Most studies have evaluated short-term infusions of vasopressin at 0.08 U/minute or less as add-on therapy in patients requiring adrenergic agents. The results show that starting vasopressin in patients with septic shock increases systemic vascular resistance and arterial blood pressure, thus reducing the dosage requirements of adrenergic agents [12]. These effects are rapid and sustained. Substantial enhancement of urine production, likely due to increased glomerular filtration rate, was shown in several studies. A few studies demonstrated clinically significant reduced cardiac output or cardiac index after vasopressin was begun, necessitating cautious use in patients with cardiac dysfunction.

3. Modulation of Septic Response:

There are a number of ways to modulate the septic response. These includes use of steroids, tight glucose control and the use of Activated Protein C. Septic shock causes adrenal suppression and this can be confirmed by measuring cortisol levels or by using the synacthan test. Compare to placebo, the administration of low dose of hydrocortisone (200-300 mg/day in divided doses) to patients with septic shock decrease there requirements for vasopressors [13] and lowered their mortality rate [14]. Low dose hydrocortisone should only be given to non responders of the synacthan test but in practice all patient receive this treatment until the result of the test are received.  Following the Corticosteroid Therapy of Septic Shock (CORTICUS) study there is now an increasing trend towards restricting the use of low dose hydrocortisone only to patients with refractory hypotension who are already on high doses on vasopressors [15]. The trial did show a faster resolution of septic shock in patients who received steroids but failed to show a mortality benefit with steroids therapy. Close control of blood glucose has been shown to increase survival in critically ill septic patient. When conservative (10 – 11.1 mol/L) glycemic control was compared with tight control (4.4-6.1mmol/L) in a multi centre, randomized controlled trial, tight control lead to a significant reduction in mortality (8% versus 4-6%), p < 0-04 and improved morbidity at 12 months [16]. 

Activated Protein C

Human activated Protein C (APC) is an endogenous regulator of coagulation. In order for protein C in the plasma to become activated, it must combine with thrombin and thrombomodulin along with the endothelial protein C receptor. With endothelial damage this activation does not take place resulting in its deficiency. Therefore APC supplementation is a rational therapeutic option. APC has an important role in the management of severe sepsis. It protects against the disruption of the endothelial cell membrane, improves micro circulatory perfusion, and has anti inflammatory, procoagulant, fibrinolytic and anti apoptotic activity. APC must ideally be started with in the first 24 hours of the onset of septic shock. The Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial found activated protein C to reduce the risk of death among all severe sepsis patients by 20% [17] This study has also recognized the risk of complications specially haemorrhages.

Subsequent studies have shown similar results. “Administration of Drotrecogin Alfa (Activated) in Early Stage Severe Sepsis” (ADDRESS trial) also provides the evidence concerning use of rhAPC in adults [18]. Additional safety information comes from an open-label observational study, “Extended Evaluation of Recombinant Activated Protein C” (ENHANCE trail). [19] The ENHANCE trial also suggested that early administration of rhAPC was associated with better outcomes.

Other beneficial Strategies in Sepsis

Low Tidal Volume Ventilation: using normal or high tidal volume (10-12mls/Kg) ventilation will cause over expansion of the normal lung segments. This will in turn result in inflammatory mediators being released in the lung tissue. The consequences of this are the development of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). Therefore it is crucial to use low tidal volume Ventilation (6ml/kg) to keep plateau airway pressure less than 30 cm of water [20, 21]

High volume Haemofilteration: In the past five years, many studies have been conducted to evaluate and demonstrate benefits of increasing the volume of ultra filtration and replacement fluid during Continuous Renal replacement therapy [22, 23] particularly in complex and very severe syndromes such as Severe Sepsis and Septic Shock, associated with or without acute renal failure.

In general, the high-volume approach provides higher clearances for middle/high molecular weight solutes than a simple diffusive transport, Continuous veno venous haemodialysis (CVVHD) or a convection-based transport at lower volumes, Continuous veno venous haemofiltration (CVVH). These solutes seem to be primarily involved in the Systemic Inflammatory Response Syndrome, which characterizes the Sepsis syndrome, and their efficient removal may thus be beneficial. [24]

Alternative approaches have been based on more efficient removal of inflammatory mediators by high cut-off hemofilters, which are characterized by an increased effective pore size. Most commercially available hemofilters do not permit a substantial elimination of cytokines because of the low cut-off point of their membranes. The use of high cut-off hemofilters is a new and effective approach to cytokine removal, but it has potentially harmful side effects, such as the loss of essential proteins like albumin [25]. 

Because the reversibility of this disease and the resultant mortality may be greatest during the earliest stages of presentation, proper sepsis management should not be confined within the walls of an Intensive Care Unit. Specific emphasis on appropriate triage to ensure prompt diagnosis of the high-risk patient is vital to the launch of a coordinated and cooperative effort by the primary treating clinician and the intensivist

Ethical Dilemmas in Septic Shock

Patient with septic shock have a high mortality and as yet there is no predictive scoring system which gives accurate predictions of outcome for individual patient. Survival from an episode and septic shock is dependent on patient’s age, number of failed organs, previous health and the time delay before the onset of medial intervention, as well as the appropriateness and quality of medical care. The resources available to us are not limitless and so difficult decisions  have to be made deciding between the potential benefits for one critically ill patient and need for several less critically ill patients. As an intensivist one must set realistic expectations which must be clearly communicated to the families concerned. As septic shock worsens and fails to respond to all therapy, one must be prepared to limit and withdraw treatment.

REFERENCES

1. Lundberg J, Perl TM. Septic shock: an analysis of outcomes for patients with onset on hospital wards vs. Intensive care units. Crit care Med 1998; 26: 1020-24
2. Vincent JL, Sakr Y, and Sprung CL, et al. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006; 34:344-353.
3. Shapiro NI, Homel MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, et al. Serum lactates as a predictor of mortality in emergency department patient with infection. Ann Emerg Med. 2005; 45: 524-8.
4. Harbarth S, Garbino J, Pugin J, et al. Inappropriate initial antimicrobial therapy and its effect on survival in a clinical trial of immunomodulating therapy for severe sepsis. Am J Med. 2003; 115:529-535.
5. Gibot S, Kolopp-Sarda MN, Bene MC, et al. Plasma level of a triggering receptor expressed on myeloid cells-1: its diagnostic accuracy in patients with suspected sepsis. Ann Intern Med. 2004; 141:9-15.
6. Surviving Sepsis Campaign. Available at:    http:// www.surviving sepsis.org/ Accessed March 6, 2007.
7. Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis C guidelines for management of severe sepsis and septic shock. Crit Care med. 2004;32: 858-873
8. Battleman DS, Callahan M, Thaler HT. Rapid antibiotic delivery and appropriate antibiotic selection reduce length of hospital stay of patients with community acquired pneumonia: link between quality of care and resource utilization. Arch Intern Medicine 2002; 162(6):682-8.
9. Levy MM, Fink MP, Marshall JC, et al. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003; 31:1250-1256.
10. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345:1368-1377
11. Emanuel Rivers. The outcome of patients presenting to the emergency department with severe sepsis or septic shock. Crit Care. 2006; 10(4): 154.
12. Obritsch MD; Bestul DJ; Jung R; Fish DN; MacLaren R. The role of vasopressin in vasodilatory septic shock. Pharmacotherapy.  2004; 24(8):1050-63 (ISSN: 0277-0008)
13. Briegel J, Frost H, Haller M, Shelling G, Kilger E, Kuprat G et. Stress doses of hydrocortisone reverse hyper dynamic septic shock: a prospective randomised double blind single centre study. Crit care Med 1999; 27:723-32.
14. Annane D, Sebille V, Charpentier C, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002; 288:862-871.
15. Sprung CL. Update on clinical trials in severe sepsis. CORTICUS trial. Program and abstracts of the Society of Critical Care department patient with infection. Ann Emerg Med 2005: 45 (524-8).
16. Van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006;354:449-461
17. Bernard GR, Vincent JL, Laterre PF, et al. Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001; 344:699-709.
18. Abraham E, Laterre PF, Garg R, et al: Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med 2005; 353:1332-1341.
19. Vincent JL, Bernard GR, Beale R, et al: Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: Further evidence for survival and safety and implications for early treatment. Crit Care Med 2005; 33:2266-2277.
20. ARDS Network Investigators. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000; 342:1301-1308.
21. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, et al. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006; 354:2564-2575.
22. Piccinni P, Dan M, Barbacini S, Carraro R, Lieta E, Marafon S, Zamperetti N, Brendolan A, D'Intini V, Tetta C, et al.: Early iso-volaemic haemofiltration in oliguric patients with septic shock. Intensive Care Med 2006, 32:80-86.
23. Reiter K, D'Intini V, Bordoni V, Baldwin I, Bellomo R, Tetta C, Brendolan A, Ronco C: High-volume hemofiltration in sepsis. Nephron 2002, 92:251-258.
24. Ronco C, Tetta C, Mariano F, Wratten ML, Bonello M, Bordoni V, Cardona X, Inguaggiato P, Pilotto L, d'Intini V, Bellomo R: Interpreting the mechanisms of continuous renal replacement therapy in sepsis: the peak concentration hypothesis. Artif Organs 2003, 27:792-801.
25. Mariano F, Fonsato V, Lanfranco G, Pohlmeier R, Ronco C, Triolo G, Camussi G, Tetta C, Passlick-Deetjen J: Tailoring high-cutoff membranes and feasible application in sepsis-associated acute renal failure: in vitro studies.Nephrol Dial Transplant 2005, 20:1116-1126.

We are in the middle of the greatest changes in mental health law in a century. This started with the introduction of the Mental Capacity Act in October 2007, continued with amendments to the Mental Health Act (MHA) in November 2008, and will finish with a final flourish when the Deprivation of Liberty Safeguards come into effect to April 2009.

But what do these changes mean for Psychiatrists and other doctors? This article explores the changes.

The Mental Health Act 1983 (as amended by the Mental Health Act 2007)

Although the structure of the Mental Health Act remains the same – for example, compulsory admission to hospital still requires the recommendations of 2 doctors and the agreement of an Approved Mental Health Professional (the replacement of the ASW), the Act has been amended in the following ways:

 All these changes need to be seen within the context of the Guiding Principles and the clarified legal status of the Code of Practice (COP).

• The MHA tells us WHAT to do
• The COP explains HOW to do it
• The Guiding Principles help us to apply the MHA and COP in INDIVIDUAL SITUATIONS

 The status of the Code of Practice

The Act makes it clear that professionals, including doctors, are expected to follow the guidance of the Code of Practice, or explain why they haven’t done so. It also makes it clear that professionals are expected to take account of a number of issues, the guiding principles, when making decisions.

The Principles:

 In the future, it is likely that doctors will be expected to justify decision making with reference to above principles.

Key Change 1: Definition of Mental Disorder:

The definition of disorders covered by the MHA is now “any disorder or disability of the mind”. This simplified definition now applies to all sections of the Act. The four forms of mental disorder (mental illness, mental impairment, severe mental impairment and psychopathic disorder) have disappeared. This potentially means some people previously excluded are now included. For example, there may be some people with an acquired brain injury who were not covered by the term “mental impairment or severe mental impairment” who could now benefit from the protections of the Act.

The Learning Disability Qualification has been introduced to preserve the status quo (e.g. under section 3, a person with a learning disability alone can only be detained for treatment or be made subject to Guardianship if that learning disability is associated with abnormally aggressive or seriously irresponsible conduct.) and now applies to all those sections that relate to longer-term compulsory treatment or care for a mental disorder (in particular section 3, section 7 (Guardianship), section 17A (Supervised Community Treatment) and forensic sections under Part 3 of the Act). It means that if the use of longer-terms forms of compulsion are being considered solely on the basis that a person has a learning disability, that disability must also be associated with abnormally aggressive or seriously irresponsible conduct. This does not, of course, preclude the use of compulsion for people who have another form of mental disorder (such as a mental illness) in addition to their learning disability.

Key Change 2: The Appropriate Medical Treatment Test

The MHA introduces a new “appropriate medical treatment” test that will apply to longer-term powers of compulsion concerned with treatment(for example, section 3 and Supervised Community Treatment ).  As a result, it will not be possible for patients to be compulsorily detained for treatment or compulsion continued unless medical treatment which is appropriate taking into account the nature and degree of the patient’s mental disorder and all other circumstances of the case is available to that patient.

“Medical treatment” includes psychological treatment, nursing, and specialist mental health habilitation, rehabilitation and care as well as medicine. It does not have to be the “perfect” treatment, but doctors will be expected to satisfy themselves that appropriate treatment, taking into account all the circumstances of the case, is available and state in their recommendations in which hospital(s) it will be available to the patient. When making recommendations for section 3, the recommending doctors will need to confirm that there will be appropriate medical treatment available, and state on the recommendation form the hospital, hospitals or part of a hospital that the treatment will be given in.

 Key Change 3: Admitting young people to suitable environments

The effect of this change is that hospital managers are placed under a duty to ensure patients under 18 who are admitted to hospital for assessment or for treatment under the legislation, or who are voluntary patients are in an environment that is suitable for their age  (subject to their needs).  There is flexibility in the amendment to allow for patients under 18 years to be placed on adult psychiatric wards where the patient’s needs are better met this way.  This is expected to come into force in 2010, by which time it is hoped new services will be available. 

Section 140 of the existing Mental Health Act has also been amended to put a duty on Primary Care Trusts to let Local Social Service Authorities know where services especially suitable for admitting young people are to be found. The amendment to section140 has already come into force.

It is also now no longer possible to admit a competent and objecting 16 or 17yr old to hospital for treatment for mental disorder on the say  of their parents.

Key Change 4: The Broadening of access to professional roles

This change widens the group of practitioners able to train to fulfil functions  previously undertaken by Approved Social Workers (ASWs) and Responsible Medical Officers (RMOs). It does this by introducing two new roles:

Approved Mental Health Professionals (AMHPs): AMHPs are mental health professionals with specialist training in mental health assessment and legislation. The training will be opened up to include mental health and learning disability nurses, clinical psychologists and occupational therapists as well as social workers. AMHPs will assess “on behalf of” Local Authorities, who will continue to be responsible for approving AMHPs and for ensuring a 24hr AMHP service is available.

The final part of this change concerns the Approved Clinician (AC), the professional status/qualification a practitioner must obtain before they can take on the responsibilities of a Responsible Clinician (RC) for a particular person.

The RC is the old Responsible Medical Officer role which has now been opened up to include social workers, mental health and learning disability nurses, clinical psychologists and occupational therapists. The RC has overall responsibility for a patient’s case. This change allows more flexibility – for example, making it possible to transfer responsibility to professionals from different groups of staff as the patient’s needs change.

Directions make it clear that all professionals who want to be a RC need to meet particular levels of competence, undertake a short course to demonstrate their state of readiness and be approved by Strategic Health Authority as an AC.

Transitional arrangements for doctors:

Doctors with Section 12 status: for doctors with section 12 status, that status will continue unaltered for as long as had been expected to. For example, a doctor whose section 12 approval was due to expire in April 10, this will still be the case.

Doctors with section 12 status who have acted as an RMO for a patient in the 12 months prior to 3^rd Nov 2008: such doctors will automatically be given Approved Clinician Status so that they can be Responsible Clinicians for people detained under the Act. If their section 12 status was due to expire during the next 12 months, it will be extended until 2^rd Nov 2009.

Doctors (such as community consultants) who are section 12 approved, have been responsible for a patient’s medical treatment but have not acted as an Responsible Medical Officer (RMO) in the 12 months prior to 3^rd Nov 08: such doctors will need to complete a course for Approved Clinicians before 2^nd Nov 09, and as long as they do so their approval will last for a full 3 year period until 2^nd Nov 2011.

In the future, a doctor (but not a professional from one of the other 4 eligible groups) who completes an Approved Clinician Course will also automatically receive section12 approval.

Accessing Approved Clinician Training:

AC training will be the responsibility of Strategic Health Authorities. Generally, people wishing to be Approved Clinicians will need to be recommended by employers – and will need to be able to demonstrate how they meet the competences for the role prior to undertaking the AC training course. The course is likely to be a few days at most, so preparatory training will be important. Each area will need to develop its own systems and policies, these are likely to be influenced by the pilot studies that have been taking place around the country in preparation for this change in the law.

 Key Change 5: Nearest Relative Changes

Changes give patients the right to make an application to court to displace their nearest relative and introduces a new ground for displacement: that the current Nearest Relative(NR) is “otherwise unsuitable for the role”. The provisions for determining who is the NR have also been amended to include civil partners on equal terms with a husband or wife.

Key Change 6: Independent Mental Health Act Advocate (IMHA) service

Gives the right for patients who are subject to compulsion to have access to advocacy services. (that is, those on section 2, 3, section 7 Guardianship, SCT and similar forensic sections. Those on short term sections such as section 136 will not be eligible) Advocates will have the right to meet with patients in private. They will also have access to patient records, where a patient with capacity gives consent, and to meet and discuss the patient with professionals, such as doctors, involved in their care. In the case of patients lacking capacity to make such decisions, access must not conflict with decisions made by a deputy, Lasting Power of Attorney (LPA) donee or Court of Protection, and the person holding the records must agree that such access is “appropriate”. The principles of the COP should be used to decide whether it is appropriate to disclose information in a particular case.

It is planned that the new “Independent Mental Health Advocacy” services will be available from April 2009.

Key change 7: ECT and Patient Rights

Except in emergencies, detained patients may in future only be given ECT if they have capacity and agree or, (as now) if they do not have capacity, the ECT is authorised by a Second Opinion Appointed Doctor (SOAD).

In other words, this means that a detained patient can refuse to have ECT, and, except in emergencies, this can be overturned only if a SOAD agrees that the patient does not have capacity to make the decision and that giving the ECT treatment would be appropriate. In this case, the SOAD also needs to be sure that there is no valid advance decision refusing the use of ECT. If such an advance decision has been made, then ECT cannot be given, except in an emergency.

In the case of young people (aged under 18), even if the patient agrees, unless it is an emergency, they may only be given ECT with the additional agreement of a SOAD. These rules apply to young people whether or not they are detained. 

In all these cases, it is only an emergency if the ECT is immediately necessary to save the patient’s life or prevent serious deterioration in their condition.

Key Change 8: Supervised Community Treatment

Introduces Supervised Community Treatment (SCT) for patients following a period of detention in hospital for treatment (mainly those on section 3 or unrestricted forensic sections such as section 37).  It will allow a small number of patients who currently disengage from support once discharged from hospital to be cared for in the community, subject to the possibility of being recalled to hospital if necessary.  This is to ensure they continue to get the treatment they need. There is no lower age limit.

As a statutory framework, SCT is intended to support such vulnerable patients (including some who may pose a risk to others) to:

• live in the community;
• help improve engagement with the care team by shifting the balance of power more in the patient’s favour;
• act upon any clinical signs of relapse at an early stage;
• be a mechanism to manage actual or potential relapse; and
• ensure that services are aware of and responsive to any changes of circumstances which arise for the patient or their carers.

The criteria for consideration of the use of SCT include:

• the person is suffering from a mental disorder and detained under s3 (or similar forensic section) for treatment;
• the need for medical treatment;
• the existence of a risk to the patient’s health or safety or that of others;
• that appropriate treatment is available; and that the patient does not need to be in hospital to receive it but does need to be liable to recall to hospital to ensure that the risk can be managed; and
• that it is necessary for the patient’s health or safety or the protection of others that the patient remains liable to recall.

Key Change 9: Changes to the Tribunal system

Changes to the MHA have introduced earlier referrals by Hospital Managers of detained patients who have not used their rights of appeal to the Tribunal.

To protect patients, everyone who is compulsorily admitted to hospital must have their detention review by the Tribunal service within the 1^st 6 months, and every 3 years after that. If the patient themselves doesn’t request a tribunal referral within the above timescales, the hospital managers must do so.

For under 18s, they must be seen annually by the tribunal.

The Secretary of State has the power to reduce further these periods for referral by Hospital Managers in the future. 

The MHA 2007 has also introduced the immediate referral of patients who have had their SCT revoked.

The structure of the Tribunal Service has been changed to provide a ‘1^st’ and ‘2^nd’ tier. The purpose of the 2^nd tier is to allow appeals and clarification of legal points, without having to use the judicial review process.

In addition, new rules have been issued as guidance for professionals about what is expected to be covered in reports to tribunals.

Key Change 10: the role of the 2nd Professional in the renewal of section 3

In addition to the Responsible Clinician, the written agreement of a second professional is needed to renew section 3.

The second professional must

• come from a different professional discipline compared with the RC
• be involved with the care of the patient
• be able to reach independent decisions
• have sufficient expertise and experience to make a judgement about whether the criteria for detention continue to be met.

Even if the RC disagrees with the view of the 2^nd Professional, they should not normally seek to find another professional. In such circumstances the section 3 would not be renewed. In very exceptional circumstances where a different opinion is sort, this must be brought to the attention of the hospital managers who are also required to consider and approve the renewal of the section.

For more information, please visit https//:mhact.csip.org.uk