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NCT Number: NCT05817851

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

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

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)

Drug

in addition of standard post-CA as the control group, patients will receive an IV high-dose vit-C 50mg/kg infusion every 6 hours, started within the hour after randomization, for 3 days. In addition, all patients will receive intravenous thiamine 200 mg twice a day for 3 days to limit the oxalate production.

Other names: Laroscorbine + Bevitine

standard treatment

Drug

no intervention Standard IV vit-C supplementation will be allowed for dosages up to 1000 mg a day from day 4 after randomization, as well as thiamin supplementation.

Primary outcomes

  1. Cumulative incidence of weaning from vasopressors at day 3 after OHCA.

    Time frame: day 3

    Cumulative incidence of weaning from vasopressors at day 3 after OHCA.

Secondary outcomes

  1. Cumulative incidence of death by refractory shock within 7 days after OHCA.

    Time frame: day 7 after OHCA

    Cumulative incidence of death by refractory shock within 7 days after OHCA.

  2. the neurological outcome at day 28 after OHCA, with mRS range from 0 to 3.

    Time frame: 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).

  3. The maximal vasopressors infusion dose within 3 days after OHCA.

    Time frame: 72 hours after OHCA

    The maximal vasopressors infusion dose within 3 days after OHCA.

  4. The delta SOFA (sepsis-related organ failure assessment score) is defined as the difference between SOFA admission and SOFA at 72 hours after OHCA.

    Time frame: 72 hours after OHCA

    Death within 72 hours will be counted as the maximum SOFA score (i.e. 24 points).

  5. The lower arterial lactate level at day 3 after OHCA.

    Time frame: 72 hours after OHCA

    The lower arterial lactate level at day 3 after OHCA.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan CHELLY

CONTACT

[email protected]

04.94.14.51.24

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Bethune

Network

Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  • University Hospital, Lille

Registry information

Official study title

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

Acronym: VICEPAC

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 18, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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