The findings are from the Prepare for Kidney Care trial, the first randomised study of its kind in the world, published in The Lancet on 5 November. The study suggests a structured, less medicalised approach without dialysis may offer an alternative without compromising a person’s overall length and quality of life.
The trial investigated whether older people living with kidney failure and multiple health conditions or frailty would benefit more from dialysis or a structured programme of care that does not include dialysis. It looked at both quality of life and survival.
The researchers aim to help patients and their families reach the best decision for them, offering by far the best evidence on this issue. They also want to influence NHS policy on care for this group of patients.
Funded by the National Institute for Health and Care Research (NIHR), the study recruited 445 participants from 31 UK kidney centres. This represents around half of all UK kidney services.
Around 75% of participants were aged 80 or over. The remaining 25% were aged 65–79 and had additional health problems.
Participants were randomly allocated to one of two approaches: prepare for renal dialysis or prepare for responsive management (a form of conservative kidney management). The study took nine years to complete, including seven years to recruit, and participants could choose to withdraw at any time.
Over an average follow-up period of 4.5 years, the team found neither approach resulted in better outcomes when length and quality of life were considered together.
Only one in four people (28%) who were preparing for dialysis went on to start treatment. Participants in both groups were more likely to die from other causes than to require dialysis, reflecting the vulnerability and complex health needs of this population.
The results do not apply to people already receiving dialysis, or to younger and fitter patients, for whom dialysis and transplantation remain standard care.
Fergus Caskey, Professor of Renal Medicine in Bristol Medical School, Consultant Nephrologist at Bristol NHS Foundation Trust and project lead, said:
“Our findings could have global implications for how kidney failure is discussed and managed in older patients living with multiple health conditions or frailty. Conservative kidney management is an active treatment that does not include dialysis. It is increasingly recognised around the world, but until now there has been limited evidence to compare both approaches.
“This trial establishes that if you are an older person with failing kidneys and other health problems, both preparing for dialysis and conservative kidney management are worth considering. Both have pros and cons. They result in similar overall length and quality of life. Neither should be the default.
“Carrying out a trial like this presented significant ethical challenges, but we worked hard to develop a trial where all participants retained their choice about taking part and could change their treatment pathway at any point.”
Dialysis can place a considerable burden on patients and families, often requiring frequent travel, regular treatments and medical procedures. It also carries the risk of complications. With costs estimated at around £35,000 per patient each year, dialysis also represents a significant commitment of NHS resources.
The trial was co-designed with patients and kidney specialists and included interviews with participants and their families to better understand their experience of the treatments.
Fiona Loud, Policy Director at the UK’s leading kidney patient support charity, Kidney Care UK, said:
“Making a treatment decision when you have kidney failure is extremely daunting, which is why it is vital that anyone facing it is given all the information, advice, and support to be able to make the right, informed, choice for them. This study has made an important contribution to something that was previously missing; data on balancing choices if someone is older and frail and has a number of other health conditions.
“But staff also need to be supported so they can support patients with the choice that works for them. These helpful findings should be studied with care and our NHS should be able to provide that care wherever a person lives.
“It should be noted that the choice of conservative care without dialysis is still an active treatment and patients can change their mind if they want to move on to dialysis.
“Thank you to all the patients and their families for taking part in this important trial - you’ve made a difference.”
The research team recommend that dialysis preparation should no longer be the default pathway for older people living with kidney failure and multiple other health problems or frailty. Instead, both treatment approaches should be presented as equally valid options, with decisions made jointly by patients and their healthcare teams.
Paper
Prepare for responsive management or renal dialysis in older people living with kidney failure and frailty or multimorbidity (Prepare for Kidney Care): a multi-centre, randomised, unblinded, phase 3, superiority trial
F Caskey et al in The Lancet