1. There was no significant difference in the risk of cardiovascular-related death or hospitalization between the personalized cooler dialysate group and standard temperature dialysate group.
2. Additionally, there was no significant difference in the mean drop of intradialytic systolic blood pressure between the two groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Cardiovascular disease is the leading cause of death in dialysis patients. The dialysate is typically set to a standard temperature of 36.5°C or 37.0°C. In recent years, many centres have begun to use a cooler dialysate for believed cardiovascular benefits hemodynamic stability during dialysis. This study, MyTEMP, was the first large-scale, cluster-randomized trial assessing the effects of cooler dialysate compared to standard temperature on cardiovascular mortality. Centres across Ontario were randomized to either personalized cooler dialysate or standardized temperature dialysate. The primary outcome was a composite of cardiovascular-related death or hospitalization. This study demonstrated that personalized cooler dialysate did not significantly reduce the risk of the primary outcome. The secondary outcome, which was the effect on the recorded drop in intradialytic systolic blood pressure, was also not significant. Limitations of this study include the small between-group difference between the two groups, as 36.5°C was used in the standard group opposed to 37.0°C. Nonetheless, this large-scale study provides high quality evidence that personalized cooler dialysate does not reduce cardiovascular mortality and hospitalization. Considering a cooler dialysate may result in greater patient discomfort, the adoption of cooler dialysate temperatures internationally should be evaluated.
Click to read the study in The Lancet
Relevant Reading: Randomized controlled trial of individualized dialysate cooling for cardiac protection in hemodialysis patients
In-Depth [cluster-randomized trial]: MyTEMP was a cluster-randomized superiority trial conducted in 84 of the 97 hemodialysis centres across Ontario, Canada. Centres were eligible if they provided maintenance hemodialysis to at least 15 different patients per week. The trial period ran for a total of 4 years between April 3, 2017 to March 31, 2021. Centres were randomized 1:1 to either personalized cooler dialysate (n=42, 8000 patients) or standard temperate dialysate (n=42, 7413). In the personalized cooler dialysate group, the dialysate temperature was set to 0.5 degrees Celsius below the patient’s pre-dialysis body temperature. Standard dialysate temperature was set at 36.5 degrees Celsius. The prespecified primary outcome was a composite of cardiovascular-related death or hospital admission with a major cardiovascular event. The mean age of enrolled participants was 66 years and 39.6% were women. The median length of follow-up was 1.8 years. The mean dialysate temperature was 35.8 and 36.4 degrees Celsius in the personalized and standard group, respectively. The primary outcome occurred in 1711 (21.4%) of the personalized cooler group versus 1658 (22.4%) of the standard temperature group (adjusted hazard ratio 1.00, 96% CI 0.89 to 1.11, p=0.93). The mean drop in intradialytic systolic blood pressure was 0.5 mmHg greater in the standard temperature group compared to the personalized cooler group (p=0.14).
Image: PD
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