MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

ABSTRACT:

Background

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").

Objective

The objective is to outline the statistical analysis plan for the MyTEMP trial.

Design

MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial.

Setting

A total of 84 dialysis centers in Ontario, Canada.

Patients

Approximately 13 500 patients will have received in-center hemodialysis at the 84 participating dialysis centers durin

SUBMITTER: Dixon SN 

PROVIDER: S-EPMC8404662 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature