UnknownPhase 2

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

Uganda60 participantsStarted 2021-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult (≥18 years old) patients presenting to the emergency department of Kiruddu National Referral Hospital (KNRH) with:
✓. 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.
✓. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion criteria

✕. Pregnant or known active breast feeding
✕. Non-severe, localized, uncomplicated infection (e.g., cellulitis with only local symptoms) which is apparent on clinical examination
✕. Severe bleeding or hemorrhagic shock
✕. Hypotension likely secondary to a cause other than sepsis or sepsis-induced cardiac insufficiency
✕. Detainee or prisoner
✕. Admission to a surgical or obstetric/gynecological ward
✕. Emergency surgery required
✕. Previously recruited to the REVISTA-DOSE study

What they're measuring

change in Vitamin C plasma concentration during the intervention period

Timeframe: during the intervention (days 1-5)

Trial details

NCT IDNCT04999137

SponsorLiverpool School of Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-29

Contact for this trial

Shevin T Jacob, MD MPH

+256.787.429365 shevin.jacob@lstmed.ac.uk

View on ClinicalTrials.gov More Sepsis trials