High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
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.