The RENAL (Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy) study: statistical analysis plan

Abstract

BACKGROUND: The Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study is the largest interventional trial ever conducted in patients with acute renal failure. OBJECTIVE: To develop and report a pre-determined statistical analysis plan which the investigators will adhere to in analysing the data from the trial. METHODS: The data collected by the researchers as part of the trial protocol was reviewed and formally assessed. Information relevant to baseline characteristics was selected and, for each item, statistically relevant descriptive elements were described. Information relevant to the process of care and delivery of prescribed trial therapy was similarly..