Personalised cooler dialysate for patients receiving maintenance haemodialysis (MyTEMP): a pragmatic, cluster-randomised trial

• Published in: The Lancet (British edition) 2022-11, Vol.400 (10364), p.1693-1703
• Main Authors: Garg, Amit X, Al-Jaishi, Ahmed A, Dixon, Stephanie N, Sontrop, Jessica M, Anderson, Sierra J, Bagga, Amit, Benjamin, Derek S, Berry, William AD, Blake, Peter G, Chambers, Laura C, Chan, Patricia CK, Delbrouck, Nicole F, Devereaux, Philip J, Goluch, Richard J, Gregor, Laura H, Grimshaw, Jeremy M, Hanson, Garth J, Illiescu, Eduard A, Jain, Arsh K, Killin, Lauren, Lok, Charmaine E, Luo, Bin, Mustafa, Reem A, Nathoo, Bharat C, Nesrallah, Gihad E, Oliver, Matt J, Pandeya, Sanjay, Parmar, Malvinder S, Perkins, David N, Presseau, Justin, Rabin, Elijah Z, Sasal, Joanna T, Shulman, Tanya S, Smith, D Michael, Sood, Manish, Steele, Andrew W, Tam, Paul YW, Tascona, Daniel J, Wadehra, Davinder B, Wald, Ron, Walsh, Michael, Watson, Paul A, Wodchis, Walter P, Zager, Philip G, Zwarenstein, Merrick, McIntyre, Christopher W
• Format: Article
• Language: English
• Subjects: Bias; Blood pressure; Body temperature; Cardiovascular disease; Cardiovascular diseases; Cerebral infarction; Clinical trials; Clusters; Coders; Cohort analysis; Cold Temperature - adverse effects; Congestive heart failure; Customization; Dialysate; Dialysis; Dialysis Solutions - adverse effects; Failure analysis; Health risks; Heart attacks; Heart failure; Hemodialysis; Hospitals; Humans; Hypotension; Ischemia; Maintenance; Mortality; Myocardial infarction; Ontario; Patient admissions; Patients; Personal health; Polls & surveys; Randomization; Renal Dialysis - methods; Research ethics; Stroke; Systematic review; Treatment Outcome
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(22)01805-0

Haemodialysis centres have conventionally provided maintenance haemodialysis using a standard dialysate temperature (eg, 36·5°C) for all patients. Many centres now use cooler dialysate (eg, 36·0°C or lower) for potential cardiovascular benefits. We aimed to assess whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate. MyTEMP was a pragmatic, two-arm, parallel-group, registry-based, open-label, cluster-randomised, superiority trial done at haemodialysis centres in Ontario, Canada. Eligible centres provided maintenance haemodialysis to at least 15 patients a week, and the medical director of each centre had to confirm that their centre would deliver the assigned intervention. Using covariate-constrained randomisation, we allocated 84 centres (1:1) to use either personalised cooler dialysate (nurses set the dialysate temperature 0·5–0·9°C below each patient's measured pre-dialysis body temperature, with a lowest recommended dialysate temperature of 35·5°C), or standard temperature dialysate (36·5°C for all patients and treatments). Patients and health-care providers were not masked to the group assignment; however, the primary outcome was recorded in provincial databases by medical coders who were unaware of the trial or the centres’ group assignment. The primary composite outcome was cardiovascular-related death or hospital admission with myocardial infarction, ischaemic stroke, or congestive heart failure during the 4-year trial period. Analysis was by intention to treat. The study is registered at ClinicalTrials.gov, NCT02628366. We assessed all of Ontario's 97 centres for inclusion into the study. Nine centres had less than 15 patients and one director requested that four of their seven centres not participate. 84 centres were recruited and on Feb 1, 2017, these centres were randomly assigned to administer personalised cooler dialysate (42 centres) or standard temperature dialysate (42 centres). The intervention period was from April 3, 2017, to March 31, 2021, and during this time the trial centres provided outpatient maintenance haemodialysis to 15 413 patients (about 4·3 million haemodialysis treatments). The mean dialysate temperature was 35·8°C in the cooler dialysate group and 36·4°C in the standard temperature group. The primary outcome occurred in 1711 (21·4%) of 8000 patients in the cooler dialysate group versus