Evaluation of Safety and Dosing of a Vitamin C Bundle for Sepsis Treatment in Africa
REVISTA-DOSE
Evaluation of Pharmacokinetics, Safety and Feasibility for Administration of Two Doses of Intravenous Vitamin C Combined With Vitamin B1 for the Management of Adult Patients Admitted With Sepsis to Kiruddu National Referral Hospital
1 other identifier
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 sepsis
Started Sep 2021
Shorter than P25 for phase_2 sepsis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2021
CompletedSeptember 8, 2021
September 1, 2021
4 months
April 6, 2021
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in Vitamin C plasma concentration during the intervention period
Vitamin C plasma concentrations will be measured during the intervention period using high-performance liquid chromatography (HPLC) with ultraviolet (UV) analysis and compared to baseline (pre-intervention) concentrations
during the intervention (days 1-5)
Secondary Outcomes (4)
Oxalate excretion in urine
during the intervention (hours 0-12 and 72-84)
Incidence of acute hemolysis
during the intervention (days 0-5)
Enrolment rates
up to 3 months
Rates of adherence to protocol
during the intervention
Other Outcomes (17)
Change in lactate level
during the intervention (hours 0, 6 and 24)
Pro-calcitonin clearance (PCT-c)
during the intervention (hours 0, 24 and 72)
Duration of hypotension assessed by systolic and mean arterial pressures during 4-day administration of vitamin C (in combination with vitamin B1)
during the intervention (hours 0-96)
- +14 more other outcomes
Study Arms (3)
Intravenous vitamin C 1.5g + intravenous vitamin B1
EXPERIMENTALintravenous vitamin C (1.5 grams) every 6 hours for 16 doses in combination with intravenous vitamin B1 (200 mg) every 12 hours
Intravenous Vitamin C 3g + intravenous vitamin B1
EXPERIMENTALIntravenous vitamin C (3 grams) every 6 hours for 16 doses in combination with intravenous vitamin B1 (200 mg) every 12 hours
Usual Care
NO INTERVENTIONUsual care
Interventions
Vitamin C (ascor), infused intravenously in 50 mls sodium chloride (NaCl) over 30 minutes every 6 hours for 16 doses
Vitamin B1 (200 mg) administered intravenously every 12 hours for 8 doses
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
- History of end stage renal disease requiring dialysis
- Current symptomatic renal stones or or a previous diagnosis of primary hyperoxaluria or oxalate nephropathy
- History of allergic reactions to vitamin C or vitamin B1
- Use of vitamin C at a dose greater than 1 g (oral or intravenous) within 24 hours of screening
- 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).
- Previous or current enrolment in a trial in which co-enrolment is not allowed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool School of Tropical Medicinelead
- Infectious Diseases Institute, Ugandacollaborator
- Walimucollaborator
- University of Copenhagencollaborator
- University of Liverpoolcollaborator
Study Sites (2)
Infectious Diseases Institute, Makerere University
Kampala, Uganda
Kiruddu National Referral Hospital
Kampala, Uganda
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shevin T Jacob, MD MPH
LSTM/IDI/Walimu
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
August 10, 2021
Study Start
September 1, 2021
Primary Completion
December 29, 2021
Study Completion
December 29, 2021
Last Updated
September 8, 2021
Record last verified: 2021-09