Haemodialysis has traditionally been conducted with dialysate of a temperature of 36.5°C, but the use of a personalised, lower-temperature dialysate is experiencing “rising popularity” with clinicians. Following the recent presentation at ASN Kidney Week by Amit Garg (Western University, London, Canada), corresponding author of the MyTEMP trial, which found that a cooler dialysate of 36°C or lower did not improve patient outcomes, the full results of that trial have now been published in The Lancet.
The study was performed across 84 haemodialysis centres across Ontario, Canada. Of these, half were assigned to use dialysate set to a standard temperature (36.5°C), while the other half used dialysate at a personalized lower temperature, 0.5-0.9°C cooler than the patient’s body temperature – as determined before the therapy – with a minimum temperature of 35.5°C.
In total, more than 15,000 patients’ outcomes were recorded by the study, making this the largest haemodialysis-care study to date in terms of number of participants. The trial was not double-blind. Instead, the primary outcomes were collected as part of routine care “by medical coders who were unaware of the trial or the centres’ group assignment.”
The primary outcome after the four-year trial period was a composite one including “cardiovascular-related death or hospital admission with myocardial infarction, ischaemic stroke, or congestive heart failure.” The composite outcome occurred in 22.4% of patients in the standard temperature dialysate group and 21.4% in the cooler dialysate group—a finding which was not considered statistically significant. The team also found no significant difference in the average drop in systolic blood pressure during dialysis between the two groups, with “26.6 mm Hg in the cooler dialysate group and 27.1 mm Hg in the standard temperature group.”
The study authors concluded that “centre-wide delivery of cooler dialysate” did not offer better outcomes to patients on the evidence they found. They said that the trend of increasing use of cooler dialysate may do little to prevent cardiovascular events, and that “the risks and benefits of cooler dialysate in some patient populations should be clarified in future trials.”
Speaking to Renal Interventions, Garg said that “what’s remarkable about the MyTEMP trial is the tremendous support of our community and the methods we used. With this support we embedded the trial into existing healthcare at nearly all haemodialysis centres in Ontario, we were able to determine whether the intervention would improve outcomes in a real-world setting that represented all patients who receive haemodialysis in routine care. The trial was strongly supported by the Ontario Renal Network and helps realize the goal of a learning healthcare system.”