Vitamin C has been shown to be associated with significant harm when used in patients with intensive care sepsis (ICU), the LOVIT study found.
In patients receiving vasopressor therapy in the intensive care unit, endpoint of death or persistent organ dysfunction on day 28 was more common in those who were randomized to IV therapy with vitamin C instead of placebo (44.5% vs. 38%). 5%, risk ratio [RR] 1.21, 95% CI 1.04-1.40), according to Francois Lamontan, MD, of the Université de Sherbrooke in Quebec, and colleagues in the New England Journal of Medicine.
Individual mortality results (35.4% vs. 31.6%, respectively) and persistent organ dysfunction (9.1% vs. 6.9%) have an unfavorable trend for the vitamin C group, but do not differ significantly:
- Mortality: RR 1.17 (95% CI 0.98-1.40)
- Persistent organ dysfunction: RR 1.30 (95% CI 0.83-2.05)
And a secondary analysis of the primary result adjusted for predetermined baseline characteristics is also not significant (RR 1.15, 95% CI 0.90-1.47).
In addition, vitamin C recipients were not at greater risk of tissue disoxia, inflammation or endothelial damage, leaving researchers unable to determine the mechanism of potential vitamin C damage, the group said.
The results of the study were also presented at the 2022 Critical Care Review Meeting.
The researchers acknowledged that there may have been confusion in the study, given the lack of information on specific pathogens, antimicrobial therapy and the presence of acute respiratory distress syndrome in study participants.
More data from ongoing vitamin C studies are expected. These include REMAP-CAP in pneumonia, LOVIT-COVID in hospitalized patients with COVID and a European study in sepsis complicated by acute respiratory distress syndrome.
Interest in vitamin IV as a potential treatment for sepsis is rooted in the belief that its antioxidant properties can reduce tissue damage caused by oxidative stress.
However, the evidence for the effectiveness of vitamin C in sepsis is not strong, as shown by a recent meta-analysis. The 2017 document, which sparked interest in vitamin C in this environment, was criticized as potentially “too good to be true”, and key data were also questioned.
Meanwhile, sepsis remains a common cause of death, even if treated in time. It is responsible for more than a third of all hospital deaths and kills 11 million people worldwide each year, according to the Lamontagne group.
The LOVIT phase III test was performed in France, Canada and New Zealand. Eligible patients are adults with sepsis who have received vasopressor therapy and have been in the intensive care unit for no more than 24 hours. All had proven or suspected infections as their primary diagnosis. Patients with contraindications to vitamin C therapy, those receiving open vitamin C, and those with withdrawal or death expected within 48 hours are excluded.
From November 2018 to July 2021, the researchers had 872 patients randomized 1: 1 to vitamin C or placebo. The experimental group received a bolus of vitamin C, while the controls received appropriate dextrose or saline. Prescribed treatments are given for 30 to 60 minutes every 6 hours to 96 hours. All other treatments are performed at the discretion of the treatment team.
The mean age is 65 years and less than 40% of patients are women. Baseline characteristics are similar between the vitamin C and placebo groups, as well as the use of concomitant interventions and life-support therapies during their stay in the intensive care unit.
Lamontagne and colleagues warned that their study was conducted in high-income countries and thus may not be generalized to lower-income countries, where sepsis rates can be much higher.
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James Lopilato is a full-time writer for Medpage Today. It covers various topics that are studied in current medical research.
Revelations
The study was funded by the Lotte and John Hecht Memorial Foundation, and Nova Biomedical Canada provided materials for the study.
Lamontagne received an institutional grant from the Lotte and John Hecht Memorial Foundation. He has also been involved in other vitamin C studies. Roche Diagnostics.
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