Early intravenous high-dose vitamin C in postcardiac arrest shock (VICEPAC): study protocol for a randomised, single-blind, open-label, multicentre, controlled trial.
Death, Sudden, Cardiac
INTENSIVE & CRITICAL CARE
Out-of-Hospital Cardiac Arrest
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
24 Sep 2024
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
e087303Informations 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.