Abstract: FR-OR66
Personalized Cooler Dialysate for Patients Receiving Maintenance Hemodialysis
Session Information
- High-Impact Clinical Trials
November 04, 2022 | Location: W415 Valencia, Orange County Convention Center‚ West Building
Abstract Time: 11:45 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Author
- Garg, Amit X., Western University, London, Ontario, Canada
Group or Team Name
- Major Outcomes with Personalized Dialysate Temperature (MyTEMP) Trial Investigators
Background
Conventionally, centers have provided maintenance hemodialysis using a standard dialysate temperature (e.g., 36.5°C or 37°C) for all patients. Many centers now use cooler dialysate (e.g., 36°C or lower) in patient care (nearly half of 273 centers in a recent international survey). This practice change is based on limited evidence (26 RCTs; total 484 patients; low quality methods).
Methods
We conducted a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial in Ontario, Canada. We assigned 84 centers (1:1) to use either (1) personalized 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 trial period was from April 2017 to March 2021. The primary outcome was a composite of cardiovascular-related death or hospital admission with myocardial infarction, ischemic stroke, or congestive heart failure. The key secondary outcome was the mean drop in intradialytic systolic blood pressure. Patient reported symptoms were collected in 10 centers.
Results
Over four years, the 84 centers provided outpatient maintenance hemodialysis to 15,413 patients (~ 4.3 million hemodialysis 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% confidence interval [CI], 0.89 to 1.11; P=0.93). The mean drop in intradialytic systolic blood pressure was 26.6 mmHg versus 27.1 mmHg, respectively (P=0.14). Patients in the cooler dialysate group were more likely to report feeling uncomfortably cold on dialysis.
Conclusion
Center-wide delivery of personalized cooler dialysate versus standard-temperature dialysate did not significantly reduce the risk of major cardiovascular events. A lack of benefit compounded by the likelihood of patient discomfort indicates that cooler dialysate should not be adopted as a center-wide policy. The role of cooler dialysate in select patient care warrants scrutiny and clarification.
Protocol: PMID 32076569
Statistical analytic plan: PMID 34471542
ClinicalTrials.gov record: NCT02628366
Funding
- Commercial Support –