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

NCT04088591 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: HM20018390
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Sepsis; Shock, Septic; ascorbic acid;

Outcome Measures

Primary Outcomes (2)

• Feasibility - number of participants recruited

  Recruitment feasibility will be measured using the number of participants enrolled over a one-year period

  12 months

• Feasibility - number of participants adherence to study protocol

  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

  96 hours

Secondary Outcomes (12)

• Change in SOFA score

  4 days

• Change in Universal Vital Assessment (UVA) score

  4 days

• Rate of acute kidney injury

  7 days

• Rate of thrombocytopenia

  7 days

• Rate of mechanical ventilation

  7 days

Study Arms (2)

Treatment arm

EXPERIMENTAL

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.

Drug: Ascorbic Acid 500Mg/Ml Inj

Placebo arm

PLACEBO COMPARATOR

The placebo is 50ml of 5% dextrose in water and will be administered 4 doses per day over a total duration of 96 hours

Drug: Dextrose in Water

Interventions

Ascorbic Acid 500Mg/Ml Inj DRUG

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

Treatment arm

Dextrose in Water DRUG

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of Rwanda: collaborator

Study Sites (1)

University Teaching Hospital of Kigali

Kigali, Rwanda

Location

MeSH Terms

Conditions

Sepsis; Shock

Interventions

Ascorbic Acid; Glucose; Water

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Hexoses; Monosaccharides; Sugars; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Dennis A Hopkinson, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 5 years after study publication.
• Access Criteria: This data will be made available to researchers who present to the authors a methodologically sound proposal for meta-analysis.

Locations

RW (1)