drugset / Trial / NCT04088591

High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda

NCT04088591

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This feasibility study serves to determine if it is possible to perform a powered randomized control trial of high-dose intravenous vitamin C (ascorbic acid) as an adjunctive medication in the management of sepsis and septic shock in Rwanda. Further data will be collected including Sequential Organ Failure Assessment (SOFA) score, Universal Vital Assessment (UVA) score, duration of vasopressors, mortality and other key indicators to possibly determine the impact of vitamin C on organ failure and clinical course. A total of 24 patients with a diagnosis of sepsis or septic shock will be recruited after obtaining informed consent at the University Teaching Hospital of Kigali (CHUK) and will be randomized in a 1:1 fashion to receive drug or placebo. Both treatment arms will receive standard treatment (intravenous fluids, antibiotics, vasopressors as needed, etc.) in addition to study drug or placebo. During the course of the study, any difficulties encountered will be recorded and will inform process improvements for a full randomized control, if it is indeed considered possible to perform the definitive trial.

Timeline

Start
2022-10
Primary completion
2023-11
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 50 mg/kg Intravenous