A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial

Bharath Kumar Tirupakuzhi Vijayaraghavan; Ramesh Venkataraman; Yamunadevi Ramanathan; Saravanan Margabandhu; Devachandran Jayakumar; Pratheema Ramachandran; Neill Kj Adhikari; Francois Lamontagne; Ruxandra Pinto; Marie-Hélène Masse; Julie Ménard; Sheila Sprague; Nagarajan Ramakrishnan

doi:10.5005/jp-journals-10071-24587

A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial

Indian J Crit Care Med. 2023 Dec;27(12):910-916. doi: 10.5005/jp-journals-10071-24587.

Affiliations

¹ Department of Critical Care Medicine, Apollo Hospitals, Chennai, Tamil Nadu, India.
² Department of Infection Control, Apollo Hospitals, Chennai, Tamil Nadu, India.
³ Department of Nephrology, Apollo Hospitals, Chennai, Tamil Nadu, India.
⁴ Department of Critical Care Medicine, Kamakshi Memorial Hospital; Apollo Specialty Hospitals, Chennai, Tamil Nadu, India.
⁵ Department of Critical Care Medicine, Apollo Specialty Hospitals, Chennai, Tamil Nadu, India.
⁶ Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
⁷ Department of Medicine, Université de Sherbrooke, Sherbrooke, Québec, Canada.
⁸ Research Centre of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.
⁹ Department of Surgery, McMaster University, Hamilton, Ontario, Canada.

Abstract

Background: The burden of sepsis is high in India and is associated with substantial morbidity and mortality. Vitamin C, an endogenous antioxidant, may improve patient outcomes.

Methods: This was a parallel-group pilot feasibility randomized controlled trial conducted at 2 intensive care units in India. Adult patients (≥18 years) with proven or suspected infection as the main diagnosis and needing a continuous intravenous vasopressor infusion were randomized to intravenous vitamin C (50 mg/kg every 6 hours for a maximum of 16 doses) or matching placebo. Primary outcomes were related to protocol adherence and feasibility (enrollment per month). The key secondary outcome was the composite of mortality or persistent organ dysfunction (POD) at day 28 after randomization.

Results: 60 patients were screened, 51 were eligible, 32 were randomized, and 30 were included in the analysis (randomized/eligible ratio: 0.63). The overall rate of enrollment was 1.5 patients per month. The median (IQR) age was 63.5 (51.0, 70.0) and 70.0% of the patients were male. In both arms, all patients received ≥90% of scheduled doses of the study drug. No patient received open-label vitamin C and there were no deviations from the glucose monitoring protocol. The composite outcome of mortality or POD at day 28 occurred in 56.3% (9/16) in the vitamin C arm as compared to 42.9% (6/14) in the placebo arm [RR: 1.31 (95% CI: 0.62, 2.76), p = 0.47].

Conclusion: In this pilot feasibility randomized controlled trial of vitamin C for adult patients with sepsis, protocol adherence was excellent and feasibility endpoints were met.

Trial registration: CTRI/2020/03/024371.

How to cite this article: Vijayaraghavan BKT, Venkataraman R, Ramanathan Y, Margabandhu S, Jayakumar D, Ramachandran P, et al. A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial. Indian J Crit Care Med 2023;27(12):910-916.

Keywords: Ascorbic acid; Developing countries; Randomized controlled trial; Sepsis.