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

NCT04088591 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ascorbic Acid 500Mg/Ml Inj

Ascorbic acid 200mg/kg/day administered upon suspicion or confirmation of sepsis every 6 hours for a total duration of 96 hours

DRUG

Dextrose in Water

50 ml of 5% dextrose in water every 6 hours for a total duration of 96 hours

Sponsors & Collaborators

  • University of Rwanda

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Dennis A Hopkinson, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-11-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088591 on ClinicalTrials.gov