A protocol to prevent kidney failure

At a school in the project area, waiting for the medical check-up. - BY SPECIAL ARRANGEMENT

A project implemented in Tamil Nadu yields the encouraging finding that end stage renal disease, which leads to the total failure of the kidneys, can be prevented at an affordable cost.

A UNIQUE epidemiological study, which combines survey, treatment and monitoring, has helped draw up a validated low-cost protocol for the prevention of chronic kidney diseases. The eight-year study, the first of its kind in the world, was done at Sriperumpudur Taluk, 40 km from Chennai, by the Kidney Help Trust.

The state of a person's health is often directly linked to his or her lifestyle. With more and more people aping Western culture, which means a sedentary lifestyle and diets high in salt, fat and calories but low on fibre, vitamins and proteins, obesity is on the rise. This, in turn, is leading to a high incidence of hypertension and diabetes. A third of India's population is obese, over half suffers from hypertension and nearly a third has diabetes. Diabetes and hypertension are the primary causes of kidney and heart diseases, stroke and blindness. Nearly a third of the cases of kidney failure are linked to diabetes and over a tenth to hypertension.

The World Health Organisation (WHO) has predicted that if the current trend continues, India will become the "diabetes capital of the world" by 2025 with over 57 million affected people. Already, according to the International Diabetes Federation, India has over 33 million diabetics, the largest number in any country.

If in the 1950s 1-3 per cent of the population was hypertensive, recent studies show that this figure has risen to 25-40 per cent, particularly in the urban areas. It is the most serious risk factor for kidney and cardiovascular diseases. A diabetic is two-four times more prone to heart disease and 30 times more susceptible to renal problems than a non-diabetic. Seventy per cent of diabetics also suffer mild to severe nerve damage and vision impairment.

According to Dr. M.K. Mani, chief nephrologist in Chennai's Apollo Hospitals and managing trustee of the Kidney Help Trust, the alarming rise in the incidence of diabetes and hypertension can be halted only by primary prevention methods; lifestyle changes do not prevent the diseases, they only postpone their onset.

A serious fallout of diabetes is end stage renal disease (ESRD) or kidney failure. Chronic kidney disease is a silent epidemic of the 21st century. Its occurrence is not confined to developed countries; it is universal. Every year, over one lakh people in India are diagnosed with ESRD, necessitating a kidney transplant or continual dialysis.

The progression to ESRD usually happens over time through the following stages:

Incipient (sub-clinical) nephropathy: It is the stage of a persistent increase above normal in the urinary albumin excretion rate, also known as microalbuminiuria; in the absence of proteinuria, it may be accompanied by hypertension.

Clinical (overt) nephropathy: In this stage there is the presence of persistent proteinuria (> 200 ug/minute or > 300mg/24 hours); and is usually accompanied by hypertension.

Advanced nephropathy: In this stage there is a significant deterioration of renal function, with a severe decline in the glomerular filtration rate (GFR) and the appearance of symptoms of uraemia and/or nephrotic syndrome.

End stage renal disease: ESRD necessitates dialysis or renal transplant.

Screening, detection, treatment and regular monitoring can help in reducing significantly the onset of ESRD.

Chronic kidney diseases, regardless of the diagnosis (that is, the type of kidney disease), include progressive kidney failure, complications from decreased kidney functioning, and development of cardiovascular diseases. There is increasing evidence that early detection and treatment prevents or delays some of these adverse outcomes.

Renal disease remains a major, though largely unrecognised, public health issue in India. An estimated one lakh people develop ESRD every year. This is in addition to a pre-existing pool of about 20 lakh sufferers. A person with ESRD requires renal replacement therapy in the form of either dialysis on a continuing basis or a renal transplant. Both are expensive options that require recurrent expenditure over the person's lifetime. Further, treatment for renal disease is still largely in the private health care sector, where the costs are high.

A large number of ESRD patients - those from rural areas and small towns where treatment is not available, and those who cannot afford the costs even where treatment is available - thus remain outside the pale of any kind of medical care.

In fact, 90 per cent of ESRD patients never see a nephrologist. A mere 9,000 are started on haemodialysis every year. But a whopping 60 per cent of them do not come back for dialysis, as they are unable to afford the programme. Nearly 20 per cent of the remaining die because of complications or inadequate dialysis. Only a small set of patients continues on maintenance dialysis. Some 20 per cent of the patients who consult a nephrologist opt for transplantation from either living related or unrelated donors.

There are no accurate figures for the number of kidney transplants done in India, as there is no national registry for organ transplants in place, a practice that is mandatory in most Western countries where graft procedures are performed routinely. Thus estimates of the number of ESRD patients and the actual number of transplants performed are at best guesstimates. It is estimated, or rather guesstimated, that fewer than 3,000 transplants are performed in the country each year; this represents a fraction of the total number of patients who require the procedure.

Most parts of India now have hospitals that have facilities to do dialysis (the purification of the blood) and kidney transplantation (grafting of a healthy kidney from a live donor or a cadaver into a patient), and these procedures are carried out with very good results. Unfortunately, the cost is extremely high. Dialysis costs Rs.15,000-20,000 a month, and will have to be continued as long as the patient lives. Over a million people are on dialysis worldwide, 90 per cent of them in the developed world, which accounts for less than 20 per cent of the world population.

Renal transplantation costs Rs.3-3.5 lakhs and requires medicines worth anywhere between Rs.10,000 and Rs.1,00,000 a year to prevent rejection of the transplant and to sustain life.

The per capita income in India is about Rs.21,000. The expenditure on health by the State and Central governments works out to around Rs.400 per capita a year. Thus, India cannot afford to treat people with chronic renal failure. The only feasible option is to prevent the disease, and cost-effectively too. For many patients early diagnosis can be the difference between life and death.

Prevention is a viable option, particularly as half the cases of chronic kidney failure can be avoided just by controlling diabetes and hypertension. For instance, just by controlling hypertension (high blood pressure) kidney failure can be postponed by four years. Constant monitoring and treatment for five years can control hypertension in over 95 per cent of people and diabetes in over 50 per cent, and that too at a cost of Rs.14.23 per capita. This is the focus of the Kidney Help Trust.

DR. MANI set up the Trust in 1996 mainly with donations given by his patients, with five doctors and two persons who had renal patients in their family. The primary aim was to help poor patients meet the expenses of renal transplantation. However, realising that providing free treatment or dialysis to the needy can at best only help a few, the Trust decided to concentrate on the prevention of kidney diseases. This basically meant early detection and treatment of diabetes and hypertension. Says Dr. Mani: "Every effort was made to keep costs down, so that the programme would be affordable by all in India and even in other poor countries."

Says Dr. Manjula Dutta, Head of Epideomology, Tamil Nadu MGR Medical University, who looked after the field work for the Trust as unpaid service during her free time: "Preventive work is actually like shooting in the foot for Dr. Mani as it means reduction in his practice. That a critical care person thought of preventive care is remarkable. But still he wanted to do it as he realised that the bulk of renal failure patients could not afford treatment. I also decided to join him in his mission."

As over 70 per cent of Indians live in rural areas without any facility for or access to health care, the Trust decided to choose a rural area for its out-reach programme. It chose six villages with a total population of 23,000 in Sriperumpudur taluk's Maduramangalur Panchayat Union, an area where trained health workers of the "Tulir Trust" were involved in providing neonatal primary care. The Kidney Help Trust trained Tulir's health workers to do the Sulphosalescetic Acid test to identify albumin in urine and the Bebedix Solution test to check the level of glucose (sugar) in the blood. The health workers were also taught to check blood pressure accurately and to detect symptoms by asking some simple questions during house visits. The demographics of the entire area was mapped and each house was given a card with details of every family member.

The health workers went to every village and invited the people for a check-up at a designated centre - the school, the panchayat office or even the shade of a tree. They went to the homes of those who were unable to come to ensure as near complete a coverage as possible.

That only 30 per cent of those surveyed were aware that they had a problem underlined the importance of screening every member of the community. After diagnosis, 25 per cent of the patients preferred to take treatment with their own doctors. Of the remainder, 79 per cent cooperated for treatment.

Some of the routine steps followed were:

Screening of every person once in 18 months with a simple set of questions to find out if he or she had swelling of the feet, difficulty in breathing, pain on passing urine, blood in the urine, felt the need to pass urine frequently (more than twice in an hour) or get up from sleep at night to pass urine, or felt pain in the back over the kidney area. A sample of urine was examined at the site for sugar and protein. Diabetics can be usually detected by finding the presence of sugar in the urine; protein leaks into the urine in around 80 per cent of patients with kidney disease. The blood pressure was recorded for all individuals over the age of five.

The second step was verification by the doctors of those who answered any of the questions in the affirmative. A doctor of the Kidney Help Trust examined those with high blood pressure (over 140/90) and those who had sugar or protein in the urine.

Initial investigation was done at the Apollo Hospitals, which agreed to do some simple tests free. The patients were monitored regularly by the doctor for blood urea, serum creatinine, blood glucose and glycated haemoglobin (a test that gives the average of the blood sugar over the preceding three months). Those with evidence of kidney disease were sent to the Apollo Hospitals, where they were investigated and treated free.

Diabetes and hypertension were treated with effective but low-cost drugs, such as glibenclamide and metformin, and reserpine, hydralazine and hydrochlorothiazide respectively, which the Kidney Help Trust provided free. The health workers monitored blood pressure every week and diabetes every three months. The dosage of medicines was adjusted to achieve good control.

Among those who cooperated for the treatment, blood pressure was controlled to ideal levels (less than 140/90) in 96 per cent, glycated haemoglobin was brought to the normal level in 52 per cent and it was significantly improved in another 25 per cent.

THE efficacy of the project was assessed after eight years by extending it to the adjacent areas with a population of around 21,000 and using it as a control group. Screening was done in both areas last year and the findings were compared.

A survey was done to find out the numerical value for the kidney function, GFR. The normal value of the GFR in Indians is between 80 and 95 ml/minute. The GFR was found to be below 80 ml/minute in just 8 per thousand in the project area and in 33 per thousand in the new area, which did not have the benefit of the project over the last eight years. Thus 25 persons had been prevented from developing kidney failure for every 1,000 people, of whom 75 per cent would have developed renal failure.

Says Dr. Manjula Dutta: "The findings hit us hard, particularly since it showed that 70 per cent of those who had kidney disease were not even aware that they had it. Between 7.5 and 10 per cent of the population either had diabetes or hypertension. The gratifying experience was that 90 per cent wanted to be examined. Now the Trust covers 50,000 people in 48 villages."

Funding for the Trust came from a number of individual and corporate donors. The total cost of the project, including the salaries of the workers and the doctors, the transport of doctors from Chennai to the project area, chemicals for the urine tests, and all the medicines used, worked out to just Rs.14.23 per capita a year. This does not take into account the tests done at the Apollo Hospitals, which were free (but this could add up to another couple of rupees per person).

Says Dr. Mani: "We believe we have established and validated a simple and effective protocol for the prevention of a large proportion of kidney failure at a very low cost. We have not measured the impact of the incidence of stroke and heart disease, which would probably be even greater than the benefits to the kidneys."

This programme can be replicated easily for small groups and even taken up by members of the community with a little help from doctors and laboratories. It can also be incorporated easily into government health programmes using the existing staff.

Dr. Jan J. Weening, president, International Society of Nephrology (ISN), and Dr. John Dirks, chairman, ISN's Commission for the Global Advancement of Nephrology and Professor Emeritus of Medicine at Toronto University, visited the project site and were convinced that the model should be replicated. Dr. Weening said the protocol would serve as a paradigm for the rest of the world. Dr. Dirks said it was particularly important as, according to projections, there would be 350 million diabetics in another two decades. And, of them, 50 million will be in India. "These are silent diseases that creep up on one and have devastating effects."

Talking about why it was important to screen large populations, Dr. Weening said it was not possible to detect a small vessel disease in one's brain or heart. "The first time you notice it is when the patient develops a stroke.... If you want to pick up those patients early, you cannot pick them up by looking at the brain or the heart, but you can pick them up by looking at the urine. You will find small traces of protein there.... If it is found at an early stage, then the patients can be treated."

Dr. Weening said the programme had drawn considerable international attention from the research papers that Dr. Mani had published in international journals. The study would have a tremendous impact in bringing down cases of stroke and heart failure and not just chronic kidney disease. It is a model worth replicating throughout the world.