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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Hospitalier Universitaire d'Amiens
ACTIVE_NOT_RECRUITING
Amiens
Centre Hospitalier Béthune
ACTIVE_NOT_RECRUITING
Béthune
Centre Hospitalier de Dieppe
RECRUITING
Dieppe
GHEF Site Marne La Vallée
RECRUITING
Jossigny
Centre Hospitalier de LENS
NOT_YET_RECRUITING
Lens
Centre Hospitalier Universitaire de LILLE
RECRUITING
Lille
Hôpital Lariboisière
NOT_YET_RECRUITING
Paris
Centre Hospitalier de Rouen
ACTIVE_NOT_RECRUITING
Rouen
Centre Hospitalier Toulon La Seyne sur Mer
RECRUITING
Toulon
Centre Hospitalier de Valenciennes
ACTIVE_NOT_RECRUITING
Valenciennes
Contact Information
Primary
Jonathan CHELLY
jonathan.chelly@ch-toulon.fr
04.94.14.51.24
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2026-01-24
Participants
Target number of participants: 234
Treatments
Active_comparator: Control group
\- 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.
Experimental: Experimental group
\- 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.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, University Hospital, Lille
Leads: Centre Hospitalier de Bethune

This content was sourced from clinicaltrials.gov