Evaluation of Safety and Dosing of a Vitamin C Bundle for Sepsis Treatment in Africa

• Status: Recruiting
• Trial end date: 2021-12-29
• Target enrollment: 0
• Participant gender: All

Summary

Open-label phase 2a Randomized Controlled Trial (RCT) assessing the pharmacokinetics of two different doses of intravenous vitamin C given alongside vitamin B1 in adult medical patients with sepsis and hypotension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Infectious Diseases Institute, Uganda; University of Copenhagen; University of Liverpool; Walimu
• Treatments: Ascorbic Acid; Thiamine; Vitamins

Criteria

Inclusion Criteria:

1. Adult (≥18 years old) patients presenting to the emergency department of Kiruddu National Referral Hospital (KNRH) with:

• suspected infection [(any of): temperature >38 degrees Celsius or <36 degrees Celsius or (in the past seven days) fevers, rigors, night sweats or antibiotic use]; AND

• systolic blood pressure (SBP) <90 mmHg

2. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.

3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

1. Pregnant or known active breast feeding

2. Non-severe, localized, uncomplicated infection (e.g., cellulitis with only local symptoms) which is apparent on clinical examination

3. Severe bleeding or hemorrhagic shock

4. Hypotension likely secondary to a cause other than sepsis or sepsis-induced cardiac insufficiency

5. Detainee or prisoner

6. Admission to a surgical or obstetric/gynecological ward

7. Emergency surgery required

8. Previously recruited to the REVISTA-DOSE study

9. History of end stage renal disease requiring dialysis

10. Current symptomatic renal stones or or a previous diagnosis of primary hyperoxaluria or oxalate nephropathy

11. History of allergic reactions to vitamin C or vitamin B1

12. Use of vitamin C at a dose greater than 1 g (oral or intravenous) within 24 hours of screening

13. Chronic disease/illness that, in the opinion of the site investigator, has a lifespan of less than 30 days unrelated to current sepsis diagnosis (e.g., advanced malignancy or neurodegenerative disease).

14. Previous or current enrolment in a trial in which co-enrolment is not allowed