Efficacy of early intravenous high-dose vitamin C in post-cardiac arrest shock: a multicenter, randomized controled to standard treatment, open label trial.

Phase 1

Recruiting

Conditions: cardiac arrest
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2022-500717-64-00

Lead Sponsor: Centre Hospitalier Bethune Beuvry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 234

Inclusion Criteria

patients still comatose (Glasgow coma scale < 8), an OHCA of presumed cardiac origin with ROSC < 60 min, 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, pre-existent severe chronic kidney disease (glomerular filtration rate < 30ml/min), moribound or chronic disease (life expectancy <1 an)., Patient with legal protective measures, Patient not covered by French national health insurance, known vit-C deficit, Patient with derpived freedom, Hyperoxaluria, Hystory of urolithiasis, pregnant women, OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc..), interval between OHCA and randomization > 4 hours, extracorporeal circulatory assistance requirement in the first 4 hours after OHCA, Hypersensitivity of active substance or méthyl parahydroxybenzoate or dipropyl, Contraindication to vitamine C (glucose-6-phosphate deshydrogenase deficiency; hemochromatosis), patients already treated with vit-C;, inclusion in another interventional study in cardiac arrest or post CA

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our main objective is to assess the efficacy of IV high-dose vit-C to reduce the need for vasopressor within the first 3 days in patients who suffered from an OHCA with a post-CA shock.;Secondary Objective: Compare between two groups the hospital mortality related to post-CA shock within the first 7 day after OHCA, Compare between two groups the survival with good neurological outcome at day 28 after OHCA., Compare between two groups the maximal dose of catecholamin infusion within the first 3 day after OHCA., Compare between two groups organ failure within the first 3 days after OHCA., Compare between two groups arterial lactate level within the first 3 days after OHCA;Primary end point(s): Cumulative incidence of weaning from vasopressors at day 3 after OHCA.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Cumulative incidence of death by refractory shock within 7 days after OHCA.;Secondary end point(s):the neurological outcome at day 28 after OHCA, assessed using the mRS (favorable neurological outcome will be considered if mRS range from 0 to 3; Unfavorable neurological outcome will be considered if mRS range from 4 to 6).;Secondary end point(s):The maximal vasopressors infusion dose within 3 days after OHCA.;Secondary end point(s):The delta SOFA (sepsis-related organ failure assessment score) is defined as the difference between SOFA admission and SOFA at 72 hours after OHCA. Death within 72 hours will be counted as the maximum SOFA score (i.e. 24 points).;Secondary end point(s):The lower arterial lactate level at day 3 after OHCA.