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Nephrology for Lawyers
A chapter in ‘Legally Important Clinical Mistakes’, Editor Charles Foster, Claerhout Publishing (due 2006).


CONTENTS:-

  1. Introduction
  2. Symptoms and signs
  3. Clinical problems
  4. Reflex Uropathy
  5. Adult Polycystic Kidney Disease
  6. Renovascular Disease
  7. General medical problems
  8. Acute renal failure
  9. Urological problems
  10. Renal replacement therapy
  11. Haemodialysis
  12. Chronic Ambulatory Peritoneal Dialysis
  13. Renal transplantation
  14. Conclusion


(1) Introduction          

Most lawyers and not a few doctors have a worrying lacuna in their knowledge about what nephrologists actually do. The speciality of renal medicine deals with the medical diseases that affect the kidney and the remainder of the urinary tract and has the same, slightly edgy relationship to urology as does cardiology to cardiac surgery and rheumatology to orthopaedics. The most important focus of nephrology is on the diseases that cause acute or chronic renal failure and its management by dialysis or renal transplantation. There are important links with common general medical problems such as diabetes and hypertension and patients who are seriously ill, for whatever reason, commonly develop partial or complete renal failure. Paediatric nephrology is even more specialised but many of these children survive into adult life with reduced kidney function so that the adult nephrologist must be familiar with the common childhood problems, which often have a congenital urological origin. There are only about 40,000 patients in the UK with end-stage renal failure being kept alive with dialysis or kidney transplants and spending on these patients represents about 2% of the NHS budget. The numbers are expanding steadily and will approach the current American Health Care budget expenditure of 10% so that the medico-legal importance of renal medicine will continue to grow. Although patient numbers are relatively small the repeated interventions which they require provide fertile ground for adverse events and these patients are no longer reluctant to seek legal redress, as they were in the past, when they were unreasonably grateful to be the recipients of a scarce medical resource. This chapter summarises the relevant medical background required by lawyers who are involved in renal clinical negligence cases and is based on the reports I have written over the last 14 years.

(2) Symptoms and signs          Back to Top

Many potentially serious renal diseases are completely asymptomatic in the initial stages, but an early diagnosis is sometimes established when increased amounts of protein or blood are detected in the urine by “stick” testing. The presence of trace haematuria, not visible to the naked eye, needs to be confirmed by microscopy and a 24hr urine collection is required for accurate measurement of heavy proteinuria. A trace or 1+ positive for proteinuria or haematuria may be found in healthy individuals but more pronounced abnormalities need, at least, to be investigated and reviewed. Symptoms of lower urinary tract infection (“cystitis”) such as frequency, dysuria and offensive smell need to be investigated by culture of a mid-stream urine and “blind” antibiotic treatment of a presumptive urinary infection without bacterial confirmation can be a risky thing to do. Many types of serious renal disease cause hypertension so that accurate measurement of the blood pressure with an appropriately sized cuff is an essential part of the clinical assessment of such patients.

Routine urinalysis and blood pressure measurement form part of the screening medical examinations performed on healthy individuals and clinical negligence claims alleging delay in diagnosis of a progressive renal problem are becoming increasingly common. Diseases such as glomerulonephritis and polycystic kidneys which often lead to end-stage renal failure (ESRF) may be picked up in this way but rarely cured by medication, so that although liability is often easy to demonstrate the chain of causation may be relatively weak. Note that high blood pressure, from whatever cause, will always accelerate progression to renal failure so that the possible loss of benefit caused by untreated hypertension is a recurring question, which is usually very difficult accurately to quantify.

Overall renal function is routinely measured by the plasma creatinine (normal range 60-120µmol/l), with an elevated value indicating renal impairment. Interpretation of a particular value is critically dependent on the patient’s size and measurement of the creatinine clearance (70-120ml/min/1.73m²) is more helpful, although often difficult to achieve in practice because of the need for a 24hr urine collection. Serial plasma creatinine measurements are often expressed as the reciprocal value to give a representation of the rate of progression of renal failure which is easier to understand; such a graphical plot is helpful in predicting the likely date for renal replacement therapy and demonstrating the benefit of therapeutic interventions.

It is relatively easy to predict the prognosis of a particular patient from simple observations when they are first seen. If renal function and blood pressure are normal and proteinuria minimal (0.5-1g/24hr) it is likely that serious problems will not develop during follow-up of many years or decades. On the other hand, a patient with a raised blood pressure, proteinuria greater than 2g/24hr and a creatinine over 200µmol/l will probably end up on dialysis within a few years.

Specialist investigations such as ultrasound, intravenous urography (IVU), CT and isotope scanning yield important information about kidney structure and relative function. Renal biopsy is the gold standard for histological diagnosis and prognosis and is a relatively safe procedure in an uncomplicated patient which can often be performed as a day case. The major risk of renal biopsy is haemorrhage, which can occur either into or around the kidney and this is increased in the presence of uncontrolled hypertension, renal impairment, impaired coagulation, obesity and poor patient co-operation. In straightforward patients macroscopic haematuria requiring a period of bed rest may occur in 3-5%, with about 2-3% of patients requiring a blood transfusion and less than 1% requiring arteriography and embolisation to stop the bleeding. I know of 4 fatalities following renal biopsy in the last 4 years, all of which occurred in predictably high risk patients. In such patients truly informed consent is an important issue and the other relevant legal points include the experience of the operator, the accuracy of ultrasound localisation of the kidney for biopsy, correction of hypertension and impaired coagulation, the adequacy of post biopsy observations and the reaction of the medical staff to serious bleeding. The decision to proceed to renal biopsy should be made by a consultant and identification of the high risk patient would help to prevent many of the serious complications which occur.

(3) Clinical problems          Back to Top

‘Glomerulonephritis’ is an immunologically-mediated inflammation affecting both kidneys which can range from the clinically trivial to a fulminant illness causing irreversible renal failure within a few weeks. Renal biopsy is usually essential although the simple tests outlined above will often predict the prognosis. Although most cases of glomerulonephritis do not show a dramatic response to treatment a few, such as those associated with systemic vasculitis, will improve and stabilise for many years with intensive and occasionally life-threatening treatment. It is common for patients to develop symptoms of renal failure only when the disease is relatively far advanced and such patients will often go to law for what they feel must have been a diagnostic delay which has led to the prospect of a lifetime of dialysis or transplantation. Although diagnostic delays are, indeed, common the lack of effective therapy often means that causation is weak and quantum is relatively small. The association between industrial solvent exposure and the development/progression of glomerulonephritis is attracting recent attention and has immense legal potential because of the widespread use of various hydrocarbons in the work place.

“Nephrotic syndrome” describes the existence of proteinuria which is sufficiently severe to reduce the serum albumin level and cause oedema formation. It is usually caused by glomerulonephritis or diabetes and fluid retention may need very large doses of diuretics for its control. It is a prothrombotic state with the increased possibility of venous or arterial thrombosis and pulmonary embolism in, perhaps, 5% of patients so that thromboprophylaxis with either aspirin or warfarin is usually appropriate. Nephrotic syndrome is rare in pregnancy, which is another prothrombotic state, but fatal pulmonary embolism has occurred with sub-optimal anticoagulation

(4) Reflex Uropathy          Back to Top

Vesicoureteric reflux (VUR) occurs if the normal valve mechanism where the ureter joins the bladder is deficient, so that micturition causes reflux of urine up to one or both kidneys. The combination of high pressure reflux and infected urine causes structural kidney damage and scarring affecting the upper and lower poles of the kidney which is detectable by isotope scanning or radiological techniques. Maintenance of a sterile urine by long-term antibiotics throughout childhood prevents further scar formation and progression to “reflux nephropathy”, in which the development of proteinuria and hypertension presage progression to ESRF in young adulthood. Scar formation can occur in utero or very early infancy and urinary infection in a young child, particularly a girl with a positive family history, needs to be taken seriously and actively investigated. General Practitioners are now familiar with the published management guidelines for urinary infection in children but there is a continuing legacy of cases from 15 or 20 years ago that are only now going into end-stage renal failure; experts’ uncertain recollection of the prevailing standards at the time often causes difficulty. The radiological changes of VUR were originally described as “chronic pyelonephritis” but this old-fashioned term should now be discarded. Similar changes can result from congenitally abnormal kidneys (renal dysplasia) and from the long-term use of combination pain killers containing phenacetin, although this is now extremely rare in this country. Meticulous control of hypertension with the ACE – inhibitor group of drugs may significantly delay or even prevent the otherwise inevitable progression of some of these patients to chronic renal failure.

(5) Adult Polycystic Kidney Disease          Back to Top

APKD is an inherited renal disease characterised by progressive cystic transformation of both kidneys which leads to hypertension, infection and progressive renal failure, typically affecting half of the children of an affected parent. Cyst enlargement can cause serious local complications such as pain or macroscopic haematuria and about 50-70% of affected patients will require dialysis or transplantation by the time they reach their sixties. About 2% of such patients will suffer potentially-fatal subarachnoid haemorrhage from the cerebral aneurysms which are sometimes associated and the sudden onset of severe headache, especially with a positive family history needs to be actively pursued. Renal cysts can usually be detected by ultrasound by the age of 30 but their appearance may be delayed and incorrect reassurance of a young patient who subsequently turns out to have the disease is an occasional cause of litigation. Other causes include death from uninvestigated subarachnoid haemorrhage and inadequate treatment of the hypertension which is invariably associated, leading to a potential loss of benefit. Most of the underlying chromosome abnormalities can be detected in the children of affected patients and it is likely that the genetic screening policies which are used in the United States will soon become established in this country.

(6) Renovascular Disease          Back to Top

Progressive arterial narrowing due to atheroma affecting the heart, brain and peripheral circulation is the single major cause of morbidity and mortality in ageing Western populations and it has become clear in the last 20 years that the renal arteries may also be involved. Renal function declines anyway from the fifth decade onwards so that older patients are more susceptible to acute renal failure occurring as a result of intercurrent surgery or common medication such as ACE-inhibitor drugs for hypertension and non-steroidal analgesics, with many of the latter available over the counter and consumed in industrial quantities. Renal artery stenosis from atheroma is an important additional cause of chronic renal failure in older patients and some cases respond to aggressive intervention such as balloon angioplasty, stent insertion or surgical reconstruction. These patients always have significant co-morbidity because of their diffuse arterial problems and intervention carries significant risks so that conservative management may be appropriate, with the patient being taken onto dialysis as and when this becomes necessary. The decision to proceed with interventional treatment requires a very full discussion of the possible risks and benefits and the individual experience of the operator is a crucial factor.

(7) General medical problems          Back to Top

Diabetes may progress to chronic renal failure and diabetic patients account for about 20% of new patients starting dialysis each year in this country. Meticulous control of blood sugar and hypertension has major benefits and the complicated patient requires joint care by the Diabetologist and Nephrologist. Significant weight reduction is usually important in the common, maturity onset diabetic, although often difficult to achieve in practice and patient compliance with a tight therapeutic regime is often less than ideal. Diabetic renal failure may worsen dramatically following radiological procedures which use intravenous contrast and these should not be undertaken without prior renoprotection with fluid loading and N-acetylcysteine.

Significant renal damage is rarely the result of simple hypertension but may occasionally occur, particularly if hypertension is severe and in Afro-Caribbean patients. Poorly treated hypertension can occasionally enter an “accelerated” phase with progression to ESRF in a matter of months. The legal issues usually involve the adequacy of blood pressure control by a General Practitioner and the rather uncertain prediction of the possible benefit from normalisation of the blood pressure.

(8) Acute renal failure          Back to Top

Any major, life-threatening illness may cause acute renal failure and common, recurring factors include sepsis, emergency surgery, radiological contrast procedures, non-steroidal drugs, ACE-inhibitors and aminoglycoside antibiotics such as gentamicin. Many cases occur in the context of ‘multiple organ system failure’ and these patients are usually taken care of by intensivists until their condition stabilises so that they can be treated with intermittent haemodialysis for the days or weeks which are necessary until their kidneys recover. The nephrologist will usually be involved in their care at some time and occasional legal cases involve the missed diagnosis of a treatable renal problem such as vasculitis in a patient with other major pathology. Mismatched blood transfusion often causes acute renal failure and this disaster continues to occur, usually due to errors in blood collection and labelling or transfusion of the wrong blood in the emergency situation. Many chemotherapeutic agents used for cancer cause renal damage, especially with repeated courses and careful assessment of renal function pre-treatment with appropriate dose reduction is not always performed adequately. Note that many tumours, such as lymphoma, can also cause renal damage by obstruction to urinary drainage so that causation in these cases may be very difficult to untangle.

(9) Urological problems          Back to Top

Urologists are often called upon to perform major surgery on patients with pre-existing renal damage caused by, for example, renal calculi, tumours or obstruction to urinary drainage. Some urologists are still unaware that a normal plasma creatinine in a malnourished elderly patient indicates overall renal function substantially less than 50% of normal and the nephrologist is often asked to help with the care of unanticipated post-operative renal failure. Such patients need careful pre-operative assessment with control of urinary sepsis, discontinuation of nephrotoxic medication such as ACE-inhibitors and non-steroidal analgesia and avoidance of dehydration. Drainage of an obstructed kidney causes a dramatic diuresis so that acute renal failure from dehydration needs to be anticipated and treated with adequate intravenous fluid replacement. Trans-urethral resection of the prostate (TURP) is the commonest urological operation performed in this country and post-operative problems in elderly patients include bleeding and the “TUR syndrome”, caused by absorption of the fluid used for irrigation during the surgery. Major complications affecting the heart and brain may result and the legal discussion usually involves the experience and supervision of the surgeon, together with the recognition and appropriate management of the post-operative problems.

Methysergide is an old fashioned but effective treatment for intractable migraine and prolonged courses cause the rare complication, in less than 1% of patients, of retroperitoneal fibrosis. This causes obstruction to one or both ureters with the development of renal failure and I have dealt with three such cases in the last 3 years. Methysergide should only be prescribed by a consultant neurologist experienced in its use and a drug ‘holiday’ of a month or two is required every 6 months, although this may be difficult to achieve in patients for whom it is, apparently, the only effective medication.

Minimally invasive, laparoscopic surgery is making a significant impact in modern urology and the reduced morbidity and inpatient stay with which it is often associated makes it attractive to patients and surgeons alike. Because the patients leave hospital after only a few days complications such as bleeding or bowel perforation may occur at home and patients must be warned about this possibility, with the absolute requirement to return to the care of their surgeon if any problems develop. Many general surgeons will have little experience of possible laparoscopic complications and admission to a different hospital for their management may lead to disaster. As urologists come to specialise entirely in laparoscopic surgery it is likely that they will have little experience of traditional ‘open’ procedures and the appropriateness of a decision to continue with a difficult laparoscopic procedure may attract legal analysis.

Ureteric damage seems to be a common complication of gynaecological procedures such as difficult hysterectomy and Caesarian section and the recognition of this injury may be immediately apparent or long delayed, with the potential for complete loss of function of an obstructed kidney. Once recognised, the urologist will be called upon to repair the damage and clinical experience is required to decide if immediate repair or nephrostomy drainage with delayed surgery is appropriate. Legal aspects of these ureteric injuries usually involve the particular experience of the gynaecologist, anticipation of the procedure which is likely to be complicated and prompt recognition and management of the ureteric damage which has occurred.

Assessment of condition and prognosis in the patient who has suffered renal damage as a result of surgery should be a matter for the nephrologist rather than the urologist and requires much more than measurement of the plasma creatinine level. Patients with recurring urological problems are likely to have had pre-operative damage to one or both kidneys and the presence of factors such as proteinuria and hypertension may significantly affect the future. Specialist tests such as isotope scans may be required to identify continuing obstruction and its likely evolution.

(10) Renal replacement therapy          Back to Top

There are about 20,000 patients in the United Kingdom with end-stage renal failure being kept alive by dialysis, with about 60% on haemodialysis (HD) and 40% on chronic ambulatory peritoneal dialysis (CAPD). Slightly more patients have a functioning renal transplant of which about 85% are from cadaver donors and about 15% from living related donors. Because only about 1500 kidney transplants are performed every year the current nationwide waiting list of about 6000 patients is steadily increasing. These numbers are very approximate.

The likelihood of ESRF increases with age so that nearly 40% of current patients are greater than 65 years old and the 10% annual growth in patient numbers is not predicted to plateau within the foreseeable future. The incidence of ESRF is associated with social deprivation and ethnic minority status and there is significant and worrying regional variation in the provision of dialysis and transplant facilities. Compared to similar European countries there is significant unmet need for these patients, especially those aged greater than 55 and equity of access is likely to be tested in the courts, particularly in view of the recent developments in Europe.

(11) Haemodialysis          Back to Top

Maintenance haemodialysis is typically performed for 4-5 hours thrice weekly and requires access to the circulation capable of supporting a blood flow of 250-300ml/min through the dialysis machine. Dialysis units may be either hospital-based or stand-alone, satellite facilities which are more conveniently situated where the patients live. About 20% of all regular haemodialysis places are provided by commercial companies and this number is rapidly increasing so that it will probably soon approach the figure of 80% found in America. In effect, NHS Trusts are contracting out the dialysis component of their patients’ overall care and there are interesting questions regarding the clinical responsibility for mishaps occurring in these units which have yet to fall under legal scrutiny.

In the United Kingdom and Europe about 10-15% of all dialysis patients die each year, compared to at least 20% in America. The reasons for national and local variations in patient survival are complex and poorly understood although some, at least, are explained by differences in case mix, patient selection and clinical practice. As with other areas within the NHS, the last 10 years have seen an increasing focus on the adequacy of dialysis care and the third edition of the National Guidelines was published in 2003. These combine a mixture of sensible, evidence-based recommendations with well meaning, if unproven, targets of care, many of which seem to have been included to try and help with the continuing battle for increased resources.

The adequacy of the dialysis prescription for a particular patient is an increasingly common negligence issue because of the serious morbidity and mortality which is associated with maintenance haemodialysis, although the current clinical guidelines are sufficiently vague to provide little help for the lawyers. Note that dialysis patients often have notes extending over decades and it is common for the dialysis records, such as they are, to be held in quite different folders from the clinical notes so that the retrieval of all available information can be very difficult indeed. A huge amount of data accumulates in a patient on long-term dialysis which requires complex information technology for its retrieval and many dialysis units, including my own, do not yet possess this capability. A UK Renal Registry is now existence which has just produced its fourth annual report, but only about half of all Renal Units are able to report their data accurately so that information about the achievement of recommended audit standards is relatively thin. Survival statistics may need to be inferred from the more detailed American database and are relatively inaccurate for providing predictions about an individual patient. Morbidity and mortality depends on factors such as age, underlying renal diagnosis and co-morbidity and this information is often simply unobtainable, so that predictions of life expectancy can only be approximate.

Arteriovenous Fistulae
Vascular access for long-term haemodialysis is best provided by the surgical creation of an arteriovenous fistula at wrist or elbow which allows the insertion of two wide-bore needles for each haemodialysis, which are removed at the end of the procedure. Only about 60% of patients have adequate blood vessels for fistula formation and in the remainder secondary methods such as central venous catheters or vascular grafts are required, particularly in older or diabetic patients whose veins are unsuitable. Unlike an AV fistula which can give trouble-free dialysis access for decades these alternative techniques carry a significant morbidity and mortality.

Fistula formation is the patient’s life-line for dialysis and needs to be performed by an experienced access surgeon, with meticulous attention to detail for optimal results. Such surgeons are in short supply and the operation is often unwisely delegated to a registrar. Delays in the timely formation of a fistula are common for a variety of reasons, so that temporary short-term access often becomes necessary. Only about half of the patients with end-stage renal failure enter dialysis programs in a planned fashion and serious problems in the remainder who require temporary access are well documented.

AV fistulae may divert a significant proportion of the blood flowing to the hand so that a “steal” syndrome results with the development of ischaemic pain and even gangrene, particularly in patients with pre-existing arterial narrowing such as diabetics. Repeated needling of the fistula may cause thrombosis or haemorrhage which is occasionally fatal. Serious swelling of the arm may result from pre-existing obstruction to venous drainage which needs to be anticipated and appropriately investigated in the high risk patient. Occasionally fistulae will become aneurysmal, particularly with unwise needling in the same place, so that surgical closure of the fistula is required. Despite all these problems a fistula is desirable in all patients and a good fistula is an important predictor of a relatively trouble-free dialysis career.

Central Venous Catheters
These catheters can be inserted percutaneously using local anaesthetic into the great veins such as the internal jugular, subclavian or, occasionally, femoral. The technique involves fully informed consent, appropriate positioning and sedation of the patient, and accurate localisation of the vein with an ultrasound probe. The skin and deeper tissues are anaesthetised, a large needle is passed into the vein and a guide wire is passed a further 10 or 15cm so that the tip will lie at the entry point to the right atrium. The needle is withdrawn, a dilator is passed over the wire to enlarge the hole in the vein, the catheter is then passed over the wire into the central circulation and the wire is withdrawn. A chest x-ray is performed to confirm satisfactory positioning of the catheter which can then be used for dialysis.

The procedure sounds straightforward but is, in fact, potentially fraught with disaster, including death. The main problem is bleeding which can be due to laceration of the vein, inadvertent puncture of the adjacent carotid artery or damage to the great veins as they enter the chest. Local bleeding will respond to pressure although compression of the trachea occasionally requires intubation and ventilation. Perforation of the distal vein causes bleeding into the chest and very prompt resuscitation is required if death from exsanguination is to be averted. Cannulation of the subclavian vein carries the additional risks of pneumothorax and subsequent venous stenosis and should be avoided whenever possible. All temporary dialysis catheters are prone to serious problems with thrombosis and infection so that survival of such access for more than a few weeks is unusual.

There are particular problems associated with the use of these catheters in long-term dialysis patients because of ongoing access problems. Repeated procedures cause venous stenosis and distortion of the anatomy, patients are often understandably apprehensive with limited co-operation and the co-existence of renal failure and hypertension increases the risk of bleeding. Wherever possible written informed consent should be obtained from the patient and many Trusts now have written policies for the use of these catheters. Ultrasound localisation should be routine and the skill and experience of the operator is of paramount importance; this is not a procedure to be delegated to a junior SHO who may previously have performed only a small number of relatively easy line insertions. Although access for dialysis is often required promptly it is rarely such an emergency that serious risks cannot be identified and minimised as much as possible. I know of five fatalities in the last 5 years from this cause and, doubtless, there have been many more; it is no surprise that such disasters go unreported and it is very difficult to obtain data on the expected and “acceptable” frequency of this occurrence. The Defence often depends on clinical need and the implied consent of the reasonable patient. Temporary line insertion is the commonest invasive procedure performed in a renal unit and the frequency of litigation from this cause is likely to increase.

Semi-permanent lines such as Permacaths are often used in patients with a limited prognosis in whom all other possibilities of access have been exhausted. They are usually placed by interventional radiologists or access surgeons with greater experience than the nephrologists who insert temporary lines, so that the risks of immediate bleeding seem to be rather less. About one third of regular dialysis patients in this country use this access, which typically lasts for no more than 12-18 months before the inevitable problems of thrombosis and infection occur. Local infection at the exit site will often respond to antibiotics but life-threatening septicaemia is not uncommon and fine clinical judgement is necessary to decide when an infected line needs to be urgently removed and alternative access established. Complications of blood stream infection include endocarditis and metastatic abscess formation and expert microbiological advice is always required both for the management of these patients and for the pursuit of litigation.

Subcutaneous vascular grafts in the arm or leg are used by about 10% of dialysis patients and placement is performed by a vascular surgeon under general anaesthetic. These grafts last no longer than a year or two and usually lead to thrombosis and infection which may need surgical removal of the graft. Interference with peripheral circulation to the limb is common and very careful patient selection is necessary in patients such as diabetics whose arterial supply is already compromised. Aneurysm formation can occasionally be resected surgically and swelling of the limb due to impaired venous drainage may improve with venoplasty and stent insertion, although these procedures are not without risk and may have only a limited benefit.

Technical Problems
The haemodialysis procedure is complicated and modern machines have a number of fail-safe systems which monitor blood flow, dialysate composition and temperature, membrane integrity and fluid removal. There are national specifications for dialysate sterility and monthly monitoring of the dialysis system is obligatory. Epidemics of Hepatitis B and C have occurred in dialysis units and strict infection control guidelines are essential, although they may not be rigidly enforced because of resource limitations. Progressive liver disease is an occasional result of hospital-acquired hepatitis which will be of increasing interest to clinical negligence lawyers in the future.

Medical Complications
Most of the mortality of long-term dialysis is due to cardiac causes and careful attention to control of blood pressure, fluid balance, diabetes and hyperlipidaemia is the cornerstone of these patients’ ongoing medical care. They need to consume a vast number of medications and follow fairly tight dietary restrictions so that perfect patient compliance is usually impossible to achieve. The adequacy of the dialysis regime for a particular patient should be monitored on a monthly basis by regular blood tests and they need to have regular outpatient contact with a consultant or other suitably experienced doctor. It is, in my opinion, unlikely that comparison of survival statistics from an individual unit with the national average will be possible in the foreseeable future because of the huge investment in data retrieval which will be necessary.

Anaemia in patients with renal failure responds to the prescription of erythropoietin with a typical average expenditure of about £3000/yr/patient. Diversion of the prescription costs to the General Practitioner has been widely used and leads to questions about the clinical responsibility for the use of this hormone, particularly when problems occur with under- or overcorrection of anaemia. A recent problem has been the development of aplastic anaemia because of antibody formation and I expect some of these cases to come to legal attention in the near future.

(12) Chronic Ambulatory Peritoneal Dialysis          Back to Top

CAPD is performed by running 2 litres of sterile dialysate through a plastic tube placed permanently in the peritoneal cavity, with absorption of waste products across the peritoneal membrane into the fluid which is then drained out after about 6 hours. The process is performed by the patient away from the hospital and is attractive to British nephrologists because it is quick to commence, relatively simple and does not require an expensive haemodialysis facility. Although many patients welcome the freedom of a treatment performed at home with only minor dietary restrictions there are some outstanding questions about patient suitability and selection. In Europe less than 10% of all dialysis patients are treated by CAPD, compared to about 40% in this country and some of this difference, at least, may reflect limitations in resources and service provision. Technique survival is unusual beyond 5-7 years, unlike haemodialysis which has been used successfully for decades in some patients. Automated peritoneal dialysis (APD) is used in about 30% of all PD patients and has significantly increased patient acceptability and technique survival.

The peritoneal catheter can be inserted percutaneously under local anaesthetic and this approach is favoured by many nephrologists, particularly in the uncomplicated patient. Because the procedure is done “blindly” there is significant scope for serious damage to intraperitoneal structures such as bowel and fatal haemorrhage has resulted from damage to the aorta, iliac vessels or mesenteric vessels. Previous abdominal surgery increases the risk of bowel adherence at the puncture site and adequate analgesia and patient co-operation are essential. Alternatively, the catheter can be inserted by a surgeon under general anaesthetic via a mini-laparotomy which reduces the risk of intra-abdominal trauma although delayed recovery from the anaesthetic in the patient with end-stage renal failure should be anticipated. It is sometimes difficult for the tip of the catheter to be placed in the optimum position within the pelvis so that manipulation or further surgery may be required. Post-operative pain and constipation usually settle within a few days, after which the patient is then trained to perform the dialysis procedure with meticulous attention to aseptic technique and they can then be discharged home. Frail, old patients are likely to require a prolonged training period and successful long-term dialysis at home, even with the provision of a maximum care package, is rather unlikely.

The main complication of CAPD is peritonitis due to bacterial contamination of the dialysate fluid, usually associated with poor technique. Most cases of CAPD peritonitis respond to antibiotic treatment for about a week, which is usually administered intraperitoneally to begin with, followed by a short oral course. The initial antibiotic regime often includes gentamicin and significant systemic absorption can occur from the dialysate despite the use of very low concentrations. Gentamicin damages the Auditory nerve and the balance mechanism in the ear is more sensitive to this complication than hearing. Ototoxicity is an invariable result of excessive gentamicin administration and although it is usually sub-clinical the effect of repeated courses is cumulative. Some patients require antibiotic treatment for peritonitis 3 or 4 times a year and the first problems may only become apparent after 2 or 3 years of PD with the development of dizziness, vertigo and nystagmus. Symptoms often resolve steadily if the gentamicin is discontinued but occasional patients are left with a significant disability and legal action results. Relevant issues include the duration and intensity of therapy, monitoring of blood levels and unwise persistence by the doctors with the technique of CAPD, rather than changing the patient to haemodialysis. Causation may be particularly difficult to establish so that a microbiologist with a particular interest in this complication is required, together with an ENT surgeon and nephrologist if the case is to be fought successfully.

Patients may become seriously ill because of CAPD peritonitis and it is a matter of fine clinical judgement whether to press on with antibiotic treatment or to remove the catheter and change to haemodialysis. Bacterial guidance from the laboratory is important because some infections, such as those due to Staphylococcus Aureus, Pseudomonas and Candida are unlikely to respond to antibiotics alone so that prompt removal of the catheter is required if the patient is not to die from overwhelming peritonitis. The patient may refuse to accept a transfer to haemodialysis in some of these cases but I suspect that others are due to the limited availability of haemodialysis places, particularly in older patients. The patient in whom catheter removal has been unwisely delayed is likely to have a very prolonged and stormy hospital course requiring repeated operations and drainage of intra-abdominal abscesses which may eventually lead to death.

Sclerosing encapsulating peritonitis (SEP) is an unusual but feared complication of PD, in which large segments of the bowel become matted together by dense fibrous tissue leading to progressive intestinal obstruction. Recurrent bacterial peritonitis is the single most important predisposing factor and it is also associated with the duration of PD, so that the frequency of cases is increasing with the recent developments which prolong the survival of the technique. About half of such patients die within the year and the legal issues usually concern the delay in transferring the patient to haemodialysis and the effectiveness of the management of episodes of recurrent peritonitis. Causation may be particularly difficult because there are occasional cases where SEP has first become manifest several months after catheter removal and apparent resolution of peritonitis.

Infection may also occur in the skin where the catheter exits the abdomen and will often respond to local measures such as antiseptic gel, antibiotics or catheter replacement. If the infection tracks around the tube then a subcutaneous abscess may result which requires surgical exploration and tube removal. A chronic exitsite infection which cannot be cured by simple measures is likely to lead to frank peritonitis, with the occasional severe complications described above. A variety of abdominal herniae are recognised complications of peritoneal dialysis because of the increased intra-abdominal pressure caused by the presence of the dialysate fluid.

(13) Renal Transplantation          Back to Top

Although there are about 6000 patients on the waiting list only about 1400 transplants are performed annually, so that delays of many years for a transplant are common and the number waiting is steadily increasing. Not all retrieved cadaver kidneys are allocated nationally and there are significant regional variations in waiting time; selection of an individual recipient is governed by factors such as tissue match, blood group, age and waiting time spent on dialysis. The majority of patients with ESRF long for the near-normal quality of life provided by a transplant but the reality is that older patients are unlikely ever to receive a kidney because of the limited numbers available. Only about 15% of all kidneys come from living related donors and this number could be doubled, as in Europe, by an appropriate injection of resources. Rewarded living donation, currently outlawed by the Human Organ Transplant Act, is now receiving a more objective appraisal than in the past and interesting developments are likely in this area. Living kidney donation has no long-term medical consequences but the surgery required for a nephroureterectomy is substantial and carries an inevitable morbidity and mortality. Potentially fatal complications include bleeding from the renal pedicle, together with venous thrombosis and pulmonary embolism for which thromboprophylaxis with heparin is usually appropriate. Pneumothorax and post-operative chest infection are recognised, minor post-operative problems and it remains to be seen whether the recent increase in popularity of laparoscopic donor nephrectomy is really associated with a lower incidence of problems.

Cadaver kidneys are preserved in ice after retrieval and the aim should be to get them into the recipient in under 24hrs so that immediate renal function occurs which is associated with a better prognosis. The transplanting surgeon depends on the skill of his colleagues at another centre who have removed the kidney and there are occasional problems with the quality of the kidney which are discovered at the time of transplantation, although these cause abandonment of the procedure only very rarely. The surgery may be complicated because of unexpected accessory vessels, a short ureteric stump or very poor recipient vessels, although the latter problem should have been excluded before the patient was put on the waiting list. Selection of the appropriate kidney to remove from a living donor depends on accurate knowledge of the vascular anatomy and occasional disasters have occurred because of unwise reliance on magnetic resonance studies rather than formal bilateral renal arteriography.

The recipient receives powerful drugs to prevent rejection from the time of surgery which need to be continued life-long and thromboprophylaxis is indicated for most of the post-operative period. Preventable disasters at the time of surgery include the use of a blood group-incompatible kidney or flushing of the kidney at the time of retrieval with water; transplants are usually lost under these circumstances. Irreversible, hyperacute rejection can occur if recipient antibodies are present which have not been detected by the sophisticated tissue typing which is performed on all potential recipients.

An ideal cadaver kidney donor is young and previously fit with no significant previous medical history, infection or malignancy. In reality, because of the shortage of donors, transplant surgeons and nephrologists are under considerable pressure to use kidneys that are less than perfect with an increased risk of a prolonged post-operative recovery period and reduced chances of long-term survival. A number of centres are currently assessing kidneys retrieved from non-heart beating donors for which the problems are increased but not necessarily unacceptable. Many patients with a limited prognosis on dialysis are desperate to receive a transplant, however uncertain, so that it may be justifiable to proceed if truly informed consent is given after a very detailed discussion of the possible risks and benefits. Some nephrologists are becoming more cautious about putting up their patients for transplantation because of litigation fears related to the quality of the kidney, degree of tissue matching, vascular co-morbidity and the long-term effects of immunosuppression.

Living donor transplantation has been described as the only operation with a potential 200% mortality so that it is considered unethical in some transplant units, particularly those in whom a serious problem has previously occurred. However, renal transplantation has become a strikingly successful treatment for ESRF and half of all transplants are currently surviving for about 15-20 years. All transplant units should be achieving a 1 year success rate greater than 80% and reliable, comparative data from named units in the United Kingdom is now becoming available. Most of the transplant losses occur in the first year and are usually due to surgical problems or rejection but after this time the attrition rate falls to no more than 2-3%/year. Subsequent losses may result from “chronic allograft nephropathy”, cardiovascular death or malignancy and these patients need careful and skilled life-long follow-up. Transplant kidney biopsy is sometimes necessary, with the risk of major complications described above.

Excessive immunosuppression with cyclosporin or Tacrolimus can itself cause graft damage and steroid doses need to be kept as low as possible to minimise complications such diabetes and osteoporosis. Although the incidence of all cancers is modestly increased in transplant recipients many of these are skin lesions whose management is fairly straightforward, although melanoma and squamous cell carcinoma cause appreciable mortality, especially with excessive exposure to sunlight. Post-transplant lymphoma is a serious problem closely related to the use of monoclonal antibody therapy for prevention of rejection; when it comes to immunosuppression more is definitely not better.

(14) Conclusion          Back to Top

The growth in nephrological clinical negligence cases in the last decade has certainly matched that seen in other area of the NHS and may even be ahead. Patient numbers and expectations are growing, survival is increasing and new opportunities for therapeutic intervention are developing. Diabetes and hypertension are reaching epidemic proportions in the general population and both of these diseases can have significant renal aspects. Surgeons are performing emergency surgery on older patients and the decline in renal function that occurs with the passage of time means the development of acute renal failure, sometimes irreversible, is no surprise. Most renal units carry a heavy workload, with inadequate resource provision, so it is unlikely that clinical negligence lawyers will find their talents underused.