Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan.

ABSTRACT:

Background

The LOVIT (Lessening Organ Dysfunction with Vitamin C) trial is a blinded multicenter randomized clinical trial comparing high-dose intravenous vitamin C to placebo in patients admitted to the intensive care unit with proven or suspected infection as the main diagnosis and receiving a vasopressor.

Objective

We aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database.

Methods

The SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses.

Results

The SAP includes a draft participant

SUBMITTER: Adhikari NK 

PROVIDER: S-EPMC9166642 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature