Status:
RECRUITING
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
Lead Sponsor:
Centre Hospitalier de Bethune
Collaborating Sponsors:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
University Hospital, Lille
Conditions:
Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Among patients admitted after an out-of-hospital cardiac arrest (OHCA) in intensive care unit (ICU), almost two thirds of patients will develop in the first hours a post-cardiac arrest (CA) shock. Thi...
Eligibility Criteria
Inclusion
- patients still comatose (Glasgow coma scale \< 8) after an OHCA of presumed cardiac origin with ROSC \< 60 min;
- and treated with a norepinephrin or an epinephrin continuous infusion during at least 30 min before randomization to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
Exclusion
- patients still comatose (Glasgow coma scale \< 8) after an OHCA of presumed cardiac origin with ROSC \< 60 min;
- and treated with a norepinephrin or an epinephrin continuous infusion ≥ 0.2µg/kg/h, within 4 hours after OHCA, during at least 30 min/h to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
- Exclusion criteria:
- minor or pregnant women;
- OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc.);
- interval between RACS and randomization \> 6 hours;
- extracorporeal circulatory assistance requirement in the first 4 hours after OHCA;
- history of urolithiasis, oxalate nephropathy or hemochromatosis;
- glucose-6-phosphate deshydrogenase deficiency; nephrolithiasis, hyperoxalyurie
- patients already treated with vit-C; known vit-C deficit;
- inclusion in another study;
- pre-existent severe chronic kidney disease (glomerular filtration rate \< 30ml/min);
- treatment limitationsor moribound
- Patient with derpived freedom or with legal protective measures.
- Patient not covered by French national health insurance
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 24 2028
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT05817851
Start Date
December 27 2023
End Date
January 24 2028
Last Update
January 6 2026
Active Locations (14)
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1
Centre Hospitalier Universitaire d'Amiens
Amiens, France
2
CH d'Arras
Arras, France
3
Centre Hospitalier Béthune
Béthune, France, 62408
4
CHI Nord-Ardennes
Charleville-Mézières, France