Actively Recruiting
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
Led by Centre Hospitalier de Bethune · Updated on 2026-05-08
234
Participants Needed
14
Research Sites
212 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier de Bethune
Lead Sponsor
C
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. This post-CA shock, combines cardiac and hemodynamic failure, generally resulting in multi-organ failure and early death in up to 35% of patients. Experimental data suggest that intravenous ascorbic acid (vitamin C) may attenuate inflammation and vascular injury related to sepsis or surgery. Preclinical and clinical studies also provide safety data of high dose intravenous vitamin C (\> 200mg/kg/day) with no significant adverse event reported and favorable impact on outcome. Experimental data also suggest beneficial effect of vitamin C in post-CA management with improvement of shock and multi-organ failure with potential benefit on neuroprotection and outcome. The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups : * Expérimental group: Standard of care care for post-CA shock + Vitamin C (Vit-C) 200mg/kg/d IV (started as early as possible, no later than 1 h after randomization + thiamin (Vit B1) 200mg every 12 h during 3 days. * Control group: Standard of care care for post CA shock according international guidelines. Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days
CONDITIONS
Official Title
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients still comatose (Glasgow coma scale < 8) after an out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin with return of spontaneous circulation (ROSC) less than 60 minutes.
- Receiving continuous infusion of norepinephrine or epinephrine for at least 30 minutes before randomization to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
- Age 18 years or older.
You will not qualify if you...
- Patients receiving norepinephrine or epinephrine infusion at doses ≥ 0.2 µg/kg/h within 4 hours after OHCA for at least 30 minutes to maintain MAP ≥ 65 mmHg.
- Minor or pregnant women.
- OHCA caused by evident extracardiac reasons such as trauma, bleeding, or poisoning.
- More than 6 hours elapsed between cardiac arrest and randomization.
- Requirement of extracorporeal circulatory assistance within 4 hours after OHCA.
- History of urolithiasis, oxalate nephropathy, or hemochromatosis.
- Glucose-6-phosphate dehydrogenase deficiency.
- Nephrolithiasis or hyperoxaluria.
- Already treated with vitamin C or known vitamin C deficiency.
- Participation in another clinical study.
- Severe chronic kidney disease with glomerular filtration rate less than 30 ml/min.
- Treatment limitations or moribund status.
- Patients deprived of freedom or under legal protective measures.
- Patients not covered by French national health insurance.
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Centre Hospitalier Universitaire d'Amiens
Amiens, France
Active, Not Recruiting
2
CH d'Arras
Arras, France
Actively Recruiting
3
Centre Hospitalier Béthune
Béthune, France, 62408
Actively Recruiting
4
CHI Nord-Ardennes
Charleville-Mézières, France
Active, Not Recruiting
5
Centre Hospitalier de Dieppe
Dieppe, France
Actively Recruiting
6
GHEF Site Marne La Vallée
Jossigny, France
Actively Recruiting
7
Centre Hospitalier de LENS
Lens, France, 62307
Actively Recruiting
8
Centre Hospitalier Universitaire de LILLE
Lille, France
Actively Recruiting
9
CH de Melun (GHSIF)
Melun, France
Active, Not Recruiting
10
Hôpital Lariboisière
Paris, France, 75475
Actively Recruiting
11
Centre Hospitalier de Rouen
Rouen, France
Actively Recruiting
12
Centre Hospitalier Toulon La Seyne sur Mer
Toulon, France
Actively Recruiting
13
Centre Hospitalier de Valenciennes
Valenciennes, France
Active, Not Recruiting
14
CH de Versailles
Versailles, France
Not Yet Recruiting
Research Team
J
Jonathan CHELLY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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