Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

ABSTRACT:

Objective

To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).

Methods

BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure.

Results

BaSICS will have 90-day mortality as its primary endpoint, which will be tested usi

SUBMITTER: Damiani LP 

PROVIDER: S-EPMC7853670 | biostudies-literature | 2020 Oct-Dec

REPOSITORIES: biostudies-literature