Dialysis should not necessarily be regarded as the default option for older people with kidney failure, the first randomised study of its kind in the world, led by the University of Bristol, has found.

The research, published in The Lancet today [4 November], suggests a structured, less medicalised approach without dialysis may offer an alternative without compromising a person’s overall length and quality of life.

The findings of the major study, which was funded by the National Institute for Health and Care Research (NIHR), are from the Prepare for Kidney Care trial. The trial investigated whether older people living with kidney failure and multiple health conditions or frailty would benefit more from dialysis or from a structured programme of care that does not include dialysis, looking at both quality of life and survival.

The aim of the study was to provide far better evidence to help patients and their families reach the best decision for them and influence NHS policy on care for this group of patients.

The trial, led by the University of Bristol in collaboration with the Bristol NHS Foundation Trust, recruited 445 participants from 31 UK kidney centres, representing around half of all UK kidney services.

Around 75% of participants were aged 80 or over, with the remaining 25% aged 65–79 and having 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), and followed over time. The study took nine years to complete, including seven years to recruit, and participants could choose to withdraw from the study at any time.

Over an average follow-up period of 4.5 years, the study 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.”

Fiona Loud, Policy Director at the UK’s leading kidney patient support charity, Kidney Care UK, explained: “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.”

Professor Fliss Murtagh, Director of the Wolfson Palliative Care Research Centre, Hull York Medical School at the University of Hull, said: “We know that many older people living with advanced illness prioritise quality of life, comfort and independence. That’s why it’s vital that patients and families are fully involved in treatment decisions, listened to and supported to make choices that reflect what matters to them most.

“This important research provides robust evidence that those experiencing kidney failure in later years have options which offer broadly equivalent outcomes. The findings will help support more personalised care, patient choice and better-informed decisions.”

Professor Smeeta Sinha, Consultant Nephrologist and NHS England National Clinical Director for Renal Services, added: "For many years, there has been limited high-quality evidence to guide some of the most difficult decisions in kidney care. This study provides important new data that challenges the assumption that dialysis should automatically be the next step for every patient with advanced kidney disease. As national policy continues to support informed choice and shared decision-making in kidney care, studies such as this are essential in strengthening the evidence base, ensuring that people are offered treatment options based on the outcomes that matter most to them.

“It is also important to recognise the extraordinary commitment of the patients, families, clinicians and researchers who made this study possible. Delivering a trial of this scale in a population often excluded from research requires remarkable perseverance and collaboration across the UK kidney community. Their efforts have generated evidence that will help inform care and decision-making for years to come.”

Dialysis can place a considerable burden on patients and families, often requiring frequent travel, regular treatments and medical procedures, while also carrying 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.

The study’s research team recommends that NHS England, devolved health bodies, the UK Kidney Association and National Institute for Health and Care Excellence (NICE) use these findings to support their guidance that both treatment approaches should be presented as equally valid options, with decisions made jointly by patients and their healthcare teams.