Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
, 21 (1), 42

Lessening Organ Dysfunction With VITamin C (LOVIT): Protocol for a Randomized Controlled Trial

Affiliations

Lessening Organ Dysfunction With VITamin C (LOVIT): Protocol for a Randomized Controlled Trial

Marie-Hélène Masse et al. Trials.

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.

Keywords: biomarkers; randomized controlled trial; sepsis; septic shock; vitamin C.

Conflict of interest statement

The authors declare that they have no competing interests.

Similar articles

See all similar articles

References

    1. Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) JAMA. 2016;315(8):801–810. doi: 10.1001/jama.2016.0287. - DOI - PMC - PubMed
    1. Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K. International Forum of Acute Care Trialists: Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016;193(3):259–272. doi: 10.1164/rccm.201504-0781OC. - DOI - PubMed
    1. Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, et al. The RECOVER Program: disability risk groups and 1-year outcome after 7 or more days of mechanical ventilation. Am J Respir Crit Care Med. 2016;194(7):831–844. doi: 10.1164/rccm.201512-2343OC. - DOI - PubMed
    1. Garland A, Olafson K, Ramsey CD, Yogendran M, Fransoo R. A population-based observational study of intensive care unit-related outcomes. With emphasis on post-hospital outcomes. Ann Am Thorac Soc. 2015;12(2):202–208. doi: 10.1513/AnnalsATS.201405-201CME. - DOI - PubMed
    1. Dugani S, Veillard J, Kissoon N. Reducing the global burden of sepsis. CMAJ. 2017;189(1):E2–E3. doi: 10.1503/cmaj.160798. - DOI - PMC - PubMed

Associated data

Feedback