Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05817851

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

Led by Centre Hospitalier de Bethune · Updated on 2026-05-08

234

Participants Needed

14

Research Sites

212 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier de Bethune

Lead Sponsor

C

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients still comatose (Glasgow coma scale < 8) after an out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin with return of spontaneous circulation (ROSC) less than 60 minutes.
  • Receiving continuous infusion of norepinephrine or epinephrine for at least 30 minutes before randomization to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
  • Age 18 years or older.
Not Eligible

You will not qualify if you...

  • Patients receiving norepinephrine or epinephrine infusion at doses ≥ 0.2 µg/kg/h within 4 hours after OHCA for at least 30 minutes to maintain MAP ≥ 65 mmHg.
  • Minor or pregnant women.
  • OHCA caused by evident extracardiac reasons such as trauma, bleeding, or poisoning.
  • More than 6 hours elapsed between cardiac arrest and randomization.
  • Requirement of extracorporeal circulatory assistance within 4 hours after OHCA.
  • History of urolithiasis, oxalate nephropathy, or hemochromatosis.
  • Glucose-6-phosphate dehydrogenase deficiency.
  • Nephrolithiasis or hyperoxaluria.
  • Already treated with vitamin C or known vitamin C deficiency.
  • Participation in another clinical study.
  • Severe chronic kidney disease with glomerular filtration rate less than 30 ml/min.
  • Treatment limitations or moribund status.
  • Patients deprived of freedom or under legal protective measures.
  • Patients not covered by French national health insurance.

AI-Screening

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Trial Site Locations

Total: 14 locations

1

Centre Hospitalier Universitaire d'Amiens

Amiens, France

Active, Not Recruiting

2

CH d'Arras

Arras, France

Actively Recruiting

3

Centre Hospitalier Béthune

Béthune, France, 62408

Actively Recruiting

4

CHI Nord-Ardennes

Charleville-Mézières, France

Active, Not Recruiting

5

Centre Hospitalier de Dieppe

Dieppe, France

Actively Recruiting

6

GHEF Site Marne La Vallée

Jossigny, France

Actively Recruiting

7

Centre Hospitalier de LENS

Lens, France, 62307

Actively Recruiting

8

Centre Hospitalier Universitaire de LILLE

Lille, France

Actively Recruiting

9

CH de Melun (GHSIF)

Melun, France

Active, Not Recruiting

10

Hôpital Lariboisière

Paris, France, 75475

Actively Recruiting

11

Centre Hospitalier de Rouen

Rouen, France

Actively Recruiting

12

Centre Hospitalier Toulon La Seyne sur Mer

Toulon, France

Actively Recruiting

13

Centre Hospitalier de Valenciennes

Valenciennes, France

Active, Not Recruiting

14

CH de Versailles

Versailles, France

Not Yet Recruiting

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Research Team

J

Jonathan CHELLY

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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