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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: University of Rwanda
• Treatments: Ascorbic Acid

Criteria

Inclusion Criteria:

• Adult patients between the ages of 18 and 80 who provide informed consent (or consent obtained by family member if patient is incapacitated) AND

• Patients with a strong suspicion or confirmation of infection AND

• Presence of organ dysfunction brought on by sepsis. This defined by an increase of two or more points in the qSOFA score

Exclusion Criteria:

• Known allergic reaction to ascorbic acid

• Pregnant patients or those who may be pregnant

• History of renal stones

• History of end-stage renal disease (ESRD) requiring dialysis

• History of glucose-6-phosphatase dehydrogenase (G6PD) deficiency

• History of hemochromatosis