Format

Send to

Choose Destination
Trials. 2020 Jan 8;21(1):42. doi: 10.1186/s13063-019-3834-1.

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

Author information

1
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
2
Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
3
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
4
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke Sherbrooke and Université de Sherbrooke, Sherbrooke, QC, Canada.
5
Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
6
Departments of Pharmacy and Critical Care, The Ottawa Hospital and Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
7
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
8
Kingston General Health Research Institute, Kingston, ON, Canada.
9
No institutional affiliation, No institutional affiliation, Sherbrooke, QC, Canada.
10
General Intensive Care Unit, Raymond Poincaré Hospital (AP-HP), Lab Inflammation & Infection, U1173 University Paris Saclay-UVSQ/INSERM, Garches, France.
11
Cardiothoracic and Vascular ICU, Auckland City Hospital, Auckland, New Zealand.
12
Medical Research Institute of New Zealand, Wellington, New Zealand.
13
School of Nursing, The University of Auckland, Auckland, New Zealand.
14
Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.
15
College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
16
Department of Critical Care Medicine, Apollo Hospitals, Chennai, India.
17
Department of Critical Care Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.
18
Department of Medicine and Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
19
Juravinski Hospital, Hamilton, ON, Canada.
20
Centre de Recherche du Centre Hospitalier Universitaire de Montréal, Montréal, QC, Canada.
21
Faculté de Médecine, Université Laval, Québec City, QC, Canada.
22
Département des soins intensifs du Centre intégré de santé et des services sociaux de Chaudière-Appalaches (Secteur Alphonse-Desjardins), Lévis, QC, Canada.
23
Department of Critical Care Research, St. Joseph's Healthcare, Hamilton, ON, Canada.
24
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
25
Department of Medecine, Université Laval and Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec, Québec City, QC, Canada.
26
Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec City, QC, Canada.
27
Ottawa Hospital Research Institute, Ottawa, ON, Canada.
28
Division of Cardiology, Department of Medicine, McMaster University, Population Health Research Institute, Hamilton, ON, Canada.
29
Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Canada and Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
30
Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
31
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. neill.adhikari@utoronto.ca.
32
Interdepartmental Division of Critical Care Medicine and Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada. neill.adhikari@utoronto.ca.
33
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke Sherbrooke and Université de Sherbrooke, Sherbrooke, QC, Canada. francois.lamontagne@usherbrooke.ca.

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

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center