VItamin C in Thermal injuRY: The VICToRY Pilot TrialA feasibility study for a seamless adaptive phase II/III multi-center randomized trial

Phase 1

Conditions: Severely burned patients
MedDRA version: 20.0Level: LLTClassification code 10006634Term: BurnSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Registration Number: EUCTR2020-000147-31-BE

Lead Sponsor: Clinical Evaluation Research Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

18 years of age or older with deep 2nd and/or 3rd degree burns, who are assessed as requiring skin grafting, and a minimum burn size = 20% Total Body Surface Area (TBSA).
Patients with smaller burns are less likely to require fluid resuscitation and their risk of morbidity and mortality is lower. Burn size will be determined by the attending physician (and confirmed by the attending surgeon if it is not the same person).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. >24 hours from admission to ICU or burn unit to assessment.
2. Patients admitted to burn unit >24 hours from injury or accident.
3. Patients who are moribund (not expected to survive the next 72 hours).
4. Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
5. Enrolment in another industry sponsored ICU interventional study
6. Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
7. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
8. Recent history of kidney stones (within the last year).