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Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Sepsis is a health problem of global importance; treatments focus on controlling infection and supporting failing organs. Recent clinical research suggests that intravenous vitamin C may decrease mortality in sepsis. We have designed a randomized controlled trial (RCT) to ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days in patients with sepsis. METHODS:LOVIT (Lessening Organ dysfunction with VITamin C) is a multicenter, parallel-group, blinded (participants, clinicians, study personnel, Steering Committee members, data analysts), superiority RCT (minimum n = 800). Eligible patients have sepsis as the diagnosis for admission to the intensive care unit (ICU) and are receiving vasopressors. Those admitted to the ICU for more than 24 h are excluded. Eligible patients are randomized to high-dose intravenous vitamin C (50 mg/kg every 6 h for 96 h) or placebo. The primary outcome is a composite of death or persistent organ dysfunction (need for vasopressors, invasive mechanical ventilation, or new and persisting renal replacement therapy) at day 28. Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia). Six subgroup analyses are planned. DISCUSSION:This RCT will provide evidence of the effect of high-dose intravenous vitamin C on patient-important outcomes in patients with sepsis. TRIAL REGISTRATION:clinicaltrials.gov, NCT03680274, first posted 21 September 2018.

SUBMITTER: Masse MH

PROVIDER: S-EPMC6950903 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial.

Masse Marie-Hélène MH Ménard Julie J Sprague Sheila S Battista Marie-Claude MC Cook Deborah J DJ Guyatt Gordon H GH Heyland Daren K DK Kanji Salmaan S Pinto Ruxandra R Day Andrew G AG Cohen Dian D Annane Djillali D McGuinness Shay S Parke Rachael R Carr Anitra A Arabi Yaseen Y Vijayaraghavan Bharath Kumar Tirupakuzhi BKT D'Aragon Frédérick F Carbonneau Élaine É Maslove David D Hunt Miranda M Rochwerg Bram B Millen Tina T Chassé Michaël M Lebrasseur Martine M Archambault Patrick P Deblois Estel E Drouin Christine C Lellouche François F Lizotte Patricia P Watpool Irene I Porteous Rebecca R Clarke France F Marinoff Nicole N Belley-Côté Émilie É Bolduc Brigitte B Walker Scott S Iazzetta John J Adhikari Neill K J NKJ Lamontagne François F

Trials 20200108 1

<h4>Background</h4>Sepsis is a health problem of global importance; treatments focus on controlling infection and supporting failing organs. Recent clinical research suggests that intravenous vitamin C may decrease mortality in sepsis. We have designed a randomized controlled trial (RCT) to ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days in patients with sepsis.<h4>Methods</h4>LOVIT (Lessening Organ dysfunction with VITamin C) is a ...[more]

PMID: 31915072

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Dataset Information

Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial.

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Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial.

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