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Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan.
Neill Kj Adhikari1,2, Ruxandra Pinto1, Andrew G Day3,4
1Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
JMIR Research Protocols
|April 14, 2022
Summary
This study outlines the statistical analysis plan for the Lessening Organ Dysfunction with Vitamin C (LOVIT) trial. The plan details how high-dose vitamin C
Area of Science:
- Critical Care Medicine
- Clinical Trials
- Statistical Analysis
Background:
- The Lessening Organ Dysfunction with Vitamin C (LOVIT) trial is a multicenter, randomized clinical trial.
- It investigates high-dose intravenous vitamin C versus placebo in critically ill patients with infection receiving vasopressors.
Purpose of the Study:
- To describe the prespecified statistical analysis plan (SAP) for the LOVIT trial.
- The SAP was finalized before database unblinding and locking.
Main Methods:
- The SAP defines primary and secondary outcomes, including planned analyses and subgroup investigations.
- The primary outcome is a composite of 28-day mortality and persistent organ dysfunction.
- Analyses will utilize a frequentist framework, employing generalized linear mixed models for the primary outcome.
Main Results:
- The SAP includes a participant flow diagram, tables, and planned figures.
- Primary outcome analysis will estimate the risk ratio and 95% confidence interval.
- Subgroup analyses will examine effects based on age, sex, frailty, illness severity, septic shock, baseline vitamin C levels, and COVID-19 status.
Conclusions:
- A comprehensive SAP has been developed for the LOVIT trial.
- Adherence to the SAP is planned for the analysis phase.
Keywords:
ascorbic acidbinomial distributioncritical carehealth datainfectionintensive careintensive care unitintravenousmortalityorganorgan dysfunctionpatientpatient outcomesepsisstatistical analysisstatistical frameworktrial databasevasopressorvitamin CMore Related Videos
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