Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 27, 2022
Date Accepted: Apr 14, 2022
Date Submitted to PubMed: Apr 14, 2022
Lessening Organ dysfunction with VITamin C (LOVIT): statistical analysis plan
ABSTRACT
Background:
Lessening Organ Dysfunction with VITamin C (LOVIT) is a blinded multicentre randomized clinical trial that compared 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:
To describe a pre-specified statistical analysis plan (SAP) for LOVIT, written 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 flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95% confidence interval in a generalized linear mixed model with binomial distribution and log link and considering site as a random effect. We will perform a secondary analysis adjusting for pre-specified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status.
Conclusions:
We have developed a SAP for the LOVIT trial and will adhere to it in the analysis phase. Clinical Trial: ClinicalTrials.gov identifier: NCT03680274 (21 September 2018)
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