High dose intra-venous Vitamin C administration to prevent mortality in patients with sepsis: A Randomized, Double-blind, Placebo-controlled trial

Amit Balachandran, (2020) High dose intra-venous Vitamin C administration to prevent mortality in patients with sepsis: A Randomized, Double-blind, Placebo-controlled trial. Masters thesis, Christian Medical College, Vellore.


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BACKGROUND: Sepsis is a syndrome of “life threatening organ dysfunction secondary to a dysregulated host response to infection”. Despite a myriad of interventions that have been tried in its management, the mortality remains high. Vitamin C is a drug that has antioxidant properties and acts as a co-factor in synthesis of important biomolecules like catecholamines. Along with biological plausibility that is evident from biochemical and animal studies, multiple observational studies have shown potential benefit of this agent in Sepsis. The benefit of Vitamin C in Sepsis, however, has not been conclusively proven in randomised clinical trials. AIM AND OBJECTIVES: This study aimed at assessing the effect of high dose intravenous Vitamin C administration in patients with sepsis. The objectives included evaluation of the effect of High dose intravenous (IV) Vitamin C administration on all-cause in-hospital mortality, time to ventilator independence, time to vasopressor independence, length of ICU stay, length of hospital stay, and new onset organ dysfunction in adult patients with sepsis and to identify its adverse effects. METHODS: This randomized, double-blind, placebo-controlled, parallel group, investigator initiated, pragmatic clinical trial was conducted in a single centre in South India. After informed consent, in-patients admitted with a diagnosis of sepsis were randomly assigned to receive IV Vitamin C 1.5g every 6 hours or a matching placebo for 4 days, along with the standard of care. The allocation was concealed and intervention was blinded. The primary outcome was in-hospital all-cause mortality. Data was collected by the primary investigator through structured questionnaire, entered through Microsoft Excel and analysed using SPSS 25.0. RESULTS: Through 21.09.2018 to 13.10.2019, 224 patients were screened for eligibility and 51 patients were randomised according to the eligibility criteria. 24 patients in the intervention group and 22 in the control group were included in the intention-to-treat analysis. The baseline characteristics were imperfectly matched, but prognostic scores at baseline (SOFA and APACHE 2) were well matched. In the ITT analysis Vitamin C administration was associated with a 31.44 % increase in in-hospital mortality (RR: 2.383, 95% 1.015 – 5.598, p=0.038), and the results were statistically significant. The per protocol and all subgroup analyses showed a trend towards harm with use of Vitamin C, all though the results were not statistically significant. There were no unexpected, significant complications with Vitamin C administration. CONCLUSIONS: Among patients with sepsis, administration of high dose intra-venous Vitamin C was associated with an increased risk of in-hospital mortality, as compared to placebo.

Item Type: Thesis (Masters)
Additional Information: 201711452
Uncontrolled Keywords: Vitamin C, Ascorbic Acid, Sepsis, Severe infection, Mortality.
Subjects: MEDICAL > General Medicine
Depositing User: Subramani R
Date Deposited: 28 Jan 2021 18:56
Last Modified: 31 Jan 2021 03:21
URI: http://repository-tnmgrmu.ac.in/id/eprint/13344

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