Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock. (NCT05817851) | Clinical Trial Compass
RecruitingPhase 2
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
France234 participantsStarted 2023-12-27
Plain-language 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. 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.