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

Cardiac Arrest Clinical Trial

— VICEPAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817851
• Other study ID #: 2022-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 27, 2023
• Est. completion date: January 24, 2026

Study information

• Verified date: June 2024
• Source: Centre Hospitalier de Bethune
• Contact: Jonathan CHELLY
• Phone: 04.94.14.51.24
• Email: jonathan.chelly[@]ch-toulon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: January 24, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)
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.
• standard treatment
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens
France	Centre Hospitalier Béthune	Béthune
France	Centre Hospitalier de Dieppe	Dieppe
France	GHEF Site Marne La Vallée	Jossigny
France	Centre Hospitalier de LENS	Lens
France	Centre Hospitalier Universitaire de LILLE	Lille
France	Hôpital Lariboisière	Paris
France	Centre Hospitalier de Rouen	Rouen
France	Centre Hospitalier Toulon La Seyne sur Mer	Toulon
France	Centre Hospitalier de Valenciennes	Valenciennes

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier de Bethune	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of weaning from vasopressors at day 3 after OHCA.	Cumulative incidence of weaning from vasopressors at day 3 after OHCA.	day 3
Secondary	Cumulative incidence of death by refractory shock within 7 days after OHCA.	Cumulative incidence of death by refractory shock within 7 days after OHCA.	day 7 after OHCA
Secondary	the neurological outcome at day 28 after OHCA, with mRS range from 0 to 3.	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).	day 28 after OHCA
Secondary	The maximal vasopressors infusion dose within 3 days after OHCA.	The maximal vasopressors infusion dose within 3 days after OHCA.	72 hours after OHCA
Secondary	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).	72 hours after OHCA
Secondary	The lower arterial lactate level at day 3 after OHCA.	The lower arterial lactate level at day 3 after OHCA.	72 hours after OHCA