High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda: a Feasibility Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Feasibility - number of participants recruited
Study Overview
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 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.
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 sepsis or septic shock in the tertiary care setting in Rwanda. Additionally, the study will also attempt to assess any impact vitamin C has on morbidity and mortality.
Specific objectives:
This feasibility study will determine the possibility of and any difficulties encountered with:
- Storage of vitamin C solution
- Obtaining informed consent
- Pharmaceutical preparation of vitamin C for intravenous administration
- Protection of Vitamin C solution from light during administration
- Nursing acquisition of vital signs during course of administration
- Acquisition of key labs
- Retrieval of data from patient chart for analysis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment arm
The study drug is ascorbic acid is 200mg/kg/day divided over 4 doses per day and delivered in 50 ml of 5% dextrose in water intravenously over a total duration of 96 hours.
Intervention: Ascorbic Acid 500Mg/Ml Inj (Drug)
Placebo arm
The placebo is 50ml of 5% dextrose in water and will be administered 4 doses per day over a total duration of 96 hours
Intervention: Dextrose in Water (Drug)
Outcomes
Primary Outcomes
Feasibility - number of participants recruited
Time Frame: 12 months
Recruitment feasibility will be measured using the number of participants enrolled over a one-year period
Feasibility - number of participants adherence to study protocol
Time Frame: 96 hours
Study protocol feasibility will be measured using the number of participants on whom all vital signs, labs, and placebo / trial drug administration is fully adhered to in a 96-hour period
Secondary Outcomes
- Change in SOFA score(4 days)
- Rate of acute kidney injury(7 days)
- Change in Universal Vital Assessment (UVA) score(4 days)
- Rate of mechanical ventilation(7 days)
- Rate of vasopressor usage(7 days)
- Length of intensive care unit stay(30 days)
- Length of hospital stay(30 days)
- Rate of thrombocytopenia(7 days)
- Duration of mechanical ventilation(7 days)
- Duration of vasopressor usage(7 days)
- Rate of in-hospital mortality(30 days)
- Rate of acute respiratory distress syndrome(7 days)