Status:
WITHDRAWN
High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
University of Rwanda
Conditions:
Sepsis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 managem...
Detailed Description
General objectives: This study will primarily determine if it is possible to perform a powered randomized control trial of the administration of intravenous high-dose vitamin C for the treatment of s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04088591
Start Date
October 1 2022
End Date
December 1 2023
Last Update
October 18 2022
Active Locations (1)
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1
University Teaching Hospital of Kigali
Kigali, Rwanda