Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.

Last updated: June 12, 2024
Sponsor: Centre Hospitalier de Bethune
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Attack (Myocardial Infarction)

Circulation Disorders

Heart Failure

Treatment

standard treatment

Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)

Clinical Study ID

NCT05817851
2022-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients still comatose (Glasgow coma scale < 8) after an OHCA of presumed cardiacorigin with ROSC < 60 min;

  • and treated with a norepinephrin or an epinephrin continuous infusion during atleast 30 min before randomization to maintain mean arterial pressure (MAP) ≥ 65mmHg.

Exclusion

Exclusion Criteria:

  • patients still comatose (Glasgow coma scale < 8) after an OHCA of presumed cardiacorigin 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 arterialpressure (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

Study Design

Total Participants: 234
Treatment Group(s): 2
Primary Treatment: standard treatment
Phase: 2
Study Start date:
December 27, 2023
Estimated Completion Date:
January 24, 2026

Connect with a study center

  • Centre Hospitalier Universitaire d'Amiens

    Amiens,
    France

    Site Not Available

  • Centre Hospitalier Béthune

    Béthune, 62408
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Caen

    Caen,
    France

    Site Not Available

  • Centre Hospitalier de Dieppe

    Dieppe,
    France

    Active - Recruiting

  • GHEF Site Marne La Vallée

    Jossigny,
    France

    Active - Recruiting

  • Centre Hospitalier de LENS

    Lens, 62307
    France

    Site Not Available

  • Centre Hospitalier Universitaire de LILLE

    Lille,
    France

    Active - Recruiting

  • Hôpital Lariboisière

    Paris, 75475
    France

    Site Not Available

  • Centre Hospitalier de Rouen

    Rouen,
    France

    Site Not Available

  • Centre Hospitalier Toulon La Seyne sur Mer

    Toulon,
    France

    Active - Recruiting

  • Centre Hospitalier de Valenciennes

    Valenciennes,
    France

    Site Not Available

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