Principal Investigators: Francois Lamontagne (University of Sherbrooke) and Neill Adhikari (University of Toronto)
Background: Treatment options for sepsis are limited to antimicrobials and supportive care (intravenous fluids, vasopressors, mechanical ventilation, renal replacement therapy). Recent preliminary evidence suggests that intravenous vitamin C may be the first therapy to mitigate the dysregulated cascade of events transforming an infection into sepsis. However, definitive practice changing evidence requires a large trial powered to detect plausible, modest, and clinically important difference in mortality.
Objectives: The LOVIT trial is a Parallel blinded randomized controlled trial that will investigate the effects of IV vitamin C vs placebo in critically ill patients.
Study Intervention: The experimental arm will receive IV vitamin C (50 mg/kg every 6 hours for 96 hours) and the control arm will receive IV placebo.
Primary Outcome: Death or persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) at 28 days.
Secondary Outcomes: Mortality and health-related quality of life at 6 months, daily organ function, global tissue dysoxia, biomarkers for inflammation, infection, and endothelial injury on days 1, 3, 7, baseline vitamin C level.
Funding: Funded by a Private Foundation.
Recruitment: We plan to recruit 800 patients at 25 Canadian ICUs. Recruitment will commence in late 2018.
Study Status: Start up phase.