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

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ClinicalTrials.gov Identifier: NCT04088591
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
University of Rwanda
Information provided by (Responsible Party):
Virginia Commonwealth University

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.


Condition or disease Intervention/treatment Phase
Sepsis Drug: Ascorbic Acid 500Mg/Ml Inj Drug: Dextrose in Water Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda: a Feasibility Trial
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin C

Arm Intervention/treatment
Experimental: 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.
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

Placebo Comparator: 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
Drug: Dextrose in Water
50 ml of 5% dextrose in water every 6 hours for a total duration of 96 hours




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Change in SOFA score [ Time Frame: 4 days ]
    SOFA is a single score based on patient status on six different biological systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status. A greater reduction in mean SOFA score is expected in treatment arm compared to placebo arm.

  2. Change in Universal Vital Assessment (UVA) score [ Time Frame: 4 days ]
    UVA is a single score based on patient temperature, heart and respiratory rates, systolic blood pressure, oxygen saturation, Glasgow coma scale score and HIV serostatus A greater reduction in mean UVA score is expected in treatment arm compared to placebo arm.

  3. Rate of acute kidney injury [ Time Frame: 7 days ]
    Proportion of patients developing acute kidney injury will be lower in treatment arm compared to placebo arm

  4. Rate of thrombocytopenia [ Time Frame: 7 days ]
    Proportion of patients developing thrombocytopenia (platelet count less than 150,000 / uL) will be lower in treatment arm compared to placebo arm

  5. Rate of mechanical ventilation [ Time Frame: 7 days ]
    Proportion of patients receiving mechanical ventilation will be lower in treatment arm compared to placebo arm

  6. Duration of mechanical ventilation [ Time Frame: 7 days ]
    Mean duration of mechanical ventilation when used will be lower in treatment arm compared to placebo arm

  7. Rate of vasopressor usage [ Time Frame: 7 days ]
    Proportion of patients receiving vasopressor will be lower in treatment arm compared to placebo arm

  8. Duration of vasopressor usage [ Time Frame: 7 days ]
    Mean duration of vasopressor when used will be lower in treatment arm compared to placebo arm

  9. Rate of acute respiratory distress syndrome [ Time Frame: 7 days ]
    Proportion of patients developing acute respiratory distress syndrome will be lower in treatment arm compared to placebo arm

  10. Length of intensive care unit stay [ Time Frame: 30 days ]
    Mean length of stay in intensive care unit will be shorter in treatment arm compared to placebo arm

  11. Length of hospital stay [ Time Frame: 30 days ]
    Mean length of stay in hospital will be shorter in treatment arm compared to placebo arm

  12. Rate of in-hospital mortality [ Time Frame: 30 days ]
    Mortality rate will be lower in treatment arm compared to placebo arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088591


Contacts
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Contact: Dennis A Hopkinson, MD 804-892-4597 Dennis.Hopkinson@vcuhealth.org
Contact: Aamer Syed, MD 804-828-9071 aamer.syed@vcuhealth.org

Locations
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Rwanda
University Teaching Hospital of Kigali
Kigali, Rwanda
Contact: Menelas Nkeshimana, MD    +250 784 732 678    mnls.nke@gmail.com   
Contact: Willy Mucyo, MD    +250 788 601 823    willy.mucyo@gmail.com   
Sponsors and Collaborators
Virginia Commonwealth University
University of Rwanda
Investigators
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Principal Investigator: Dennis A Hopkinson, MD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04088591    
Other Study ID Numbers: HM20018390
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data will be shared, after de-identification, to researchers who present to the authors a methodologically sound proposal for meta-analysis. Proposals should be directed to dahopk@gmail.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Virginia Commonwealth University:
Sepsis; Shock, Septic; ascorbic acid;
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients