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

NCT05817851 | Recruiting Phase 2

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 14

Brief 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

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  day 7 after OHCA

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

  day 28 after OHCA

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

  72 hours after OHCA

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

  72 hours after OHCA

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

  72 hours after OHCA

Study Arms (2)

Control group

ACTIVE COMPARATOR

\- Control group (standard treatment): post-cardiac arrest care will be provided, including temperature control, according to current international guidelines and local procedures. 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.

Drug: standard treatment

Experimental group

EXPERIMENTAL

\- Experimental group (IV high-dose vit-C): 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.

Drug: Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)

Interventions

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.

Also known as: Laroscorbine + Bevitine

Experimental group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;
• 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

Sponsors & Collaborators

• Centre Hospitalier de Bethune: lead
• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: collaborator
• University Hospital, Lille: collaborator

Study Sites (14)

Centre Hospitalier Universitaire d'Amiens

Amiens, France

ACTIVE NOT RECRUITING

CH d'Arras

Arras, France

RECRUITING

Centre Hospitalier Béthune

Béthune, 62408, France

RECRUITING

CHI Nord-Ardennes

Charleville-Mézières, France

ACTIVE NOT RECRUITING

Centre Hospitalier de Dieppe

Dieppe, France

RECRUITING

GHEF Site Marne La Vallée

Jossigny, France

RECRUITING

Centre Hospitalier de LENS

Lens, 62307, France

RECRUITING

Centre Hospitalier Universitaire de LILLE

Lille, France

RECRUITING

CH de Melun (GHSIF)

Melun, France

ACTIVE NOT RECRUITING

Hôpital Lariboisière

Paris, 75475, France

RECRUITING

Centre Hospitalier de Rouen

Rouen, France

RECRUITING

Centre Hospitalier Toulon La Seyne sur Mer

Toulon, France

RECRUITING

Centre Hospitalier de Valenciennes

Valenciennes, France

ACTIVE NOT RECRUITING

CH de Versailles

Versailles, France

NOT YET RECRUITING

Related Publications (1)

• Chelly J, Peres N, Sboui G, Maizel J, Beuzelin M, Nigeon O, Preau S, Vong LVP, Tamion F, Lambiotte F, Deye N, Bertrand T, Behal H, Ducros L, Vinsonneau C. Early intravenous high-dose vitamin C in postcardiac arrest shock (VICEPAC): study protocol for a randomised, single-blind, open-label, multicentre, controlled trial. BMJ Open. 2024 Sep 24;14(9):e087303. doi: 10.1136/bmjopen-2024-087303.

  PMID: 39317492 DERIVED

MeSH Terms

Conditions

Heart Arrest

Interventions

Ascorbic Acid; Thiamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Jonathan CHELLY

CONTACT

04.94.14.51.24; jonathan.chelly@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups : * Expérimental group * Control group Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 18, 2023
• Study Start: December 27, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 24, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)