Title :

Early intravenous high-dose vitamin C in postcardiac arrest shock (VICEPAC): study protocol for a randomised, single-blind, open-label, multicentre, controlled trial

Author(s) :

Chelly, Jonathan [Auteur]
Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse
Peres, Noemie [Auteur]
Hôpital Nord [CHU - APHM]
Centre d'études et de recherche sur les services de santé et la qualité de vie [CEReSS]
Sboui, Ghada [Auteur]
Maizel, Julien [Auteur]
Mécanismes physiopathologiques et conséquences des calcifications cardiovasculaires - UR UPJV 7517 [MP3CV]
CHU Amiens-Picardie
Beuzelin, Marion [Auteur]
CHU Rouen
Nigeon, Olivier [Auteur]
Preau, Sebastien [Auteur]
Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 [RID-AGE]
Vong, Ly van Phach [Auteur]
Grand Hôpital de l'Est Francilien [GHEF]
Tamion, Fabienne [Auteur]
Endothélium, valvulopathies et insuffisance cardiaque [EnVI]
Hôpital Charles Nicolle [Rouen]
Lambiotte, Fabien [Auteur]
Centre hospitalier [Valenciennes, Nord]
Deye, Nicolas [Auteur]
Service de Réanimation Médicale et Toxicologique [Hôpital Lariboisière]
Bertrand, Thibaut [Auteur]
Behal, Hélène [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Ducros, Laurent [Auteur]
Vinsonneau, Christophe [Auteur]
Centre Hospitalier de Béthune [CH Béthune]

Journal title :

BMJ Open

Pages :

e087303

Publisher :

BMJ Publishing Group

Publication date :

2024-09-24

ISSN :

2044-6055

English keyword(s) :

Death
Sudden
Cardiac
INTENSIVE & CRITICAL CARE
Out-of-Hospital Cardiac Arrest

HAL domain(s) :

Sciences du Vivant [q-bio]/Médecine humaine et pathologie/Cardiologie et système cardiovasculaire

English abstract : [en]

Introduction The high incidence of morbidity and mortality associated with the post-cardiac arrest (CA) period highlights the need for novel therapeutic interventions to improve the outcome of out-of-hospital cardiac arrest ...
Show more >Introduction The high incidence of morbidity and mortality associated with the post-cardiac arrest (CA) period highlights the need for novel therapeutic interventions to improve the outcome of out-of-hospital cardiac arrest (OHCA) patients admitted to the intensive care unit (ICU). The aim of this study is to assess the ability of high-dose intravenous vitamin C (Vit-C) to improve post-CA shock. Methods and analysis This is a single-blind, open-label, multicentre, randomised controlled trial, involving 234 OHCA patients with post-CA shock planned to be enrolled in 10 French ICUs. Patients will be randomised to receive standard-of-care (SOC) or SOC with early high-dose intravenous Vit-C administration (200 mg/kg per day, within 6 hours after return of spontaneous circulation, for 3 days). The primary endpoint is the cumulative incidence of vasopressor withdrawal at 72 hours after enrolment, with death considered as a competing event. The main secondary endpoints are neurological outcome, mortality due to refractory shock, vasopressor-free days and organ failure monitored by the sequential organ failure assessment score. Ethics and dissemination The study protocol was approved by a French Ethics Committee (EC) on 21 February 2023 ( Comité de Protection des Personnes Ile de France 1 , Paris, France). Due to the short enrolment period to avoid any delay in treatment, the EC approved the study inclusion before informed consent was obtained. As soon as possible, patient and their relative will be asked for their deferred informed consent. The data from the study will be disseminated through conference presentations and peer-reviewed publications. Trial registration number NCT05817851 .Show less >

Language :

Anglais

Popular science :

Non

Collections :

• Facteurs de risque et déterminants moléculaires des maladies liées au vieillissement (RID-AGE) - U1167

Source :

Harvested from HAL