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


Background — Conventionally, healthcare centres have provided maintenance haemodialysis using a 15 standard dialysate temperature (e.g., 36·5°C) for all patients. Many centres now use cooler dialysate (e.g. 36°C or lower) for potential cardiovascular benefits. The MyTEMP trial assessed whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related deaths and hospitalisations compared with standard-temperature dialysate.

Methods — MyTEMP was a pragmatic, two-arm, parallel-group, registry-based, open-label, cluster-randomised, superiority trial done at 84 of Ontario’s 97 haemodialysis centres (Canada). Using covariate-constrained randomisation, we allocated 84 centres (1:1) to use either (1) 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 (2) standard-temperature dialysate (36·5°C for all patients and treatments). The primary composite outcome was cardiovascular-related death or hospital admission with myocardial infarction, ischaemic stroke, or congestive heart failure during the four-year trial period. The key secondary outcome was the mean  drop in intradialytic systolic blood pressure. Analysis was by intention to treat. The study is registered at ClinicalTrials.gov, NCT02628366.

Findings — Between April 3, 2017 and March 31, 2021, the 84 centres provided outpatient maintenance haemodialysis to 15 413 patients (~4·3 million haemodialysis treatments). The mean dialysate temperature was 35·8°C in the cooler dialysate group versus 36·4°C in the standard-temperature group. The primary outcome occurred in 1711 of 8000 patients (21·4%) in the cooler dialysate group versus 1658 of 7413 patients (22·4%) in the standard-temperature group; adjusted hazard ratio, 1·00 (96% CI, 34 0·89 to 1·11; p=0·93). The mean drop in intradialytic systolic blood pressure was 26·6 mm Hg versus 27·1 35 mm Hg, respectively; mean difference, -0·5 mm Hg; 99% CI -1·4 to 0·4 (p=0·14).

Interpretation — Centre-wide delivery of personalised cooler dialysate versus standard-temperature dialysate did not significantly reduce the risk of major cardiovascular events. The rising popularity of cooler dialysate is called into question by this study.



The MyTEMP writing committee. Lancet. 2022; 400(1034):1693-703. Epub 2022 Nov 4.

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