Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial Academic Article uri icon

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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.

authors

  • Masse, Marie-Hélène
  • Ménard, Julie
  • Sprague, Sheila Ann
  • Battista, Marie-Claude
  • Cook, Deborah
  • Guyatt, Gordon
  • Heyland, Daren K
  • Kanji, Salmaan
  • Pinto, Ruxandra
  • Day, Andrew G
  • Cohen, Dian
  • Annane, Djillali
  • McGuinness, Shay
  • Parke, Rachael
  • Carr, Anitra
  • Arabi, Yaseen
  • Vijayaraghavan, Bharath Kumar Tirupakuzhi
  • D’Aragon, Frédérick
  • Carbonneau, Élaine
  • Maslove, David
  • Hunt, Miranda
  • Rochwerg, Bram
  • Millen, Tina
  • Chassé, Michaël
  • Lebrasseur, Martine
  • Archambault, Patrick
  • Deblois, Estel
  • Drouin, Christine
  • Lellouche, François
  • Lizotte, Patricia
  • Watpool, Irene
  • Porteous, Rebecca
  • Clarke, France
  • Marinoff, Nicole
  • Belley-Cote, Emilie
  • Bolduc, Brigitte
  • Walker, Scott
  • Iazzetta, John
  • Adhikari, Neill KJ
  • Lamontagne, François

publication date

  • December 2020