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


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
24 Sep 2024
Historique:
medline: 25 9 2024
pubmed: 25 9 2024
entrez: 24 9 2024
Statut: epublish

Résumé

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. 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. The study protocol was approved by a French Ethics Committee (EC) on 21 February 2023 ( NCT05817851.

Identifiants

pubmed: 39317492
pii: bmjopen-2024-087303
doi: 10.1136/bmjopen-2024-087303
doi:

Substances chimiques

Ascorbic Acid PQ6CK8PD0R

Banques de données

ClinicalTrials.gov
['NCT05817851']

Types de publication

Journal Article Clinical Trial Protocol Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

e087303

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Auteurs

Jonathan Chelly (J)

Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d'Azu, France JONATHAN.CHELLY@ch-toulon.fr.
Délégation à la Recherche Clinique et à L'innovation du GHT 83, Toulon, France.

Noemie Peres (N)

Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d'Azu, France.

Ghada Sboui (G)

Service de Médecine Intensive Réanimation, Centre Hospitalier de Béthune, Bethune, Nord-Pas de Calais, France.

Julien Maizel (J)

Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, Hauts-de-France, France.

Marion Beuzelin (M)

Intensive Care Unit, Centre Hospitalier de Dieppe, Dieppe, France.

Olivier Nigeon (O)

Intensive Care Unit, Centre Hospitalier de Lens, Lens, France.

Sebastien Preau (S)

Intensive Care Unit, CHU de Lille, Lille, Hauts-de-France, France.

Ly Van Phach Vong (LVP)

Marne-La-Vallee Hospital, Jossigny, Île-de-France, France.

Fabienne Tamion (F)

Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Rouen, Rouen, Normandie, France.

Fabien Lambiotte (F)

Service de Médecine Intensive Réanimation, Centre Hospitalier de Valenciennes, Valenciennes, Nord-Pas de Calais, France.

Nicolas Deye (N)

Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Assistance Publique - Hopitaux de Paris, Paris, France.

Thibaut Bertrand (T)

Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d'Azu, France.

Hélène Behal (H)

Biostatistics Department, CHU de Lille, Lille, Hauts-de-France, France.

Laurent Ducros (L)

Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d'Azu, France.

Christophe Vinsonneau (C)

Service de Médecine Intensive Réanimation, Centre Hospitalier de Béthune, Bethune, Nord-Pas de Calais, France.

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Classifications MeSH