High-dose Vitamin C for patients after cardiac arrest shock

Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock: a Multicenter, Randomized Controled Trial.

This study is testing if giving high-dose Vitamin C to patients who have had a cardiac arrest and are in shock can help them recover better than just standard treatment alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier de Bethune (Research network)
• Locations: 14 sites (Amiens and 13 other locations)
• Trial ID: NCT05817851 on ClinicalTrials.gov

What this trial studies

This phase II multicenter trial investigates the efficacy of early intravenous high-dose Vitamin C in patients who have experienced an out-of-hospital cardiac arrest and are in shock. The study aims to determine if Vitamin C can reduce inflammation and vascular injury, potentially improving outcomes such as shock resolution and multi-organ function. Patients will be randomized into two groups, one receiving Vitamin C along with standard treatment and the other receiving standard treatment alone. The trial focuses on patients who are still comatose and require continuous infusion of norepinephrine or epinephrine to maintain blood pressure.

Who should consider this trial

Good fit: Ideal candidates are patients who are comatose after an out-of-hospital cardiac arrest with a return of spontaneous circulation within 60 minutes and require vasopressor support.

Not a fit: Patients who have a cardiac arrest from non-cardiac causes or those requiring extracorporeal circulatory support are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and neurological outcomes for patients recovering from cardiac arrest.

How similar studies have performed: While there is some preclinical and clinical evidence supporting the use of high-dose Vitamin C in similar contexts, this specific approach in post-cardiac arrest management is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Amiens and 13 other locations

• Centre Hospitalier Universitaire d'Amiens — Amiens, France (Active_not_recruiting)
• CH d'Arras — Arras, France (Recruiting)
• Centre Hospitalier Béthune — Béthune, France (Recruiting)
• CHI Nord-Ardennes — Charleville-Mézières, France (Active_not_recruiting)
• Centre Hospitalier de Dieppe — Dieppe, France (Recruiting)
• GHEF Site Marne La Vallée — Jossigny, France (Recruiting)
• Centre Hospitalier de LENS — Lens, France (Recruiting)
• Centre Hospitalier Universitaire de LILLE — Lille, France (Recruiting)
• CH de Melun (GHSIF) — Melun, France (Active_not_recruiting)
• Hôpital Lariboisière — Paris, France (Recruiting)
• Centre Hospitalier de Rouen — Rouen, France (Recruiting)
• Centre Hospitalier Toulon La Seyne sur Mer — Toulon, France (Recruiting)
• Centre Hospitalier de Valenciennes — Valenciennes, France (Active_not_recruiting)
• CH de Versailles — Versailles, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Jonathan CHELLY

Conditions Cardiac Arrest