MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial
MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial
Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) is a 4-year cluster-randomized clinical trial comparing the effect of using a personalized, temperature-reduced dialysate protocol versus a dialysate temperature of 36.5°C on cardiovascular-related death and hospitalization. Randomization was performed at the level of the dialysis center ("the cluster").The objective is to outline …