Early intravenous high-dose vitamin C in postcardiac arrest shock (VICEPAC): study protocol for a randomised, single-blind, open-label, multicentre, controlled trial
Fabienne Tamion,
Hélène Behal,
Nicolas Deye,
Fabien Lambiotte,
Julien Maizel,
Christophe Vinsonneau,
Jonathan Chelly,
Sebastien Preau,
Ly Van Phach Vong,
Noemie Peres,
Ghada Sboui,
Marion Beuzelin,
Olivier Nigeon,
Thibaut Bertrand,
Laurent Ducros
Affiliations
Fabienne Tamion
Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Rouen, Rouen, Normandie, France
Hélène Behal
Biostatistics Department, CHU de Lille, Lille, Hauts-de-France, France
Nicolas Deye
Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Assistance Publique - Hopitaux de Paris, Paris, France
Fabien Lambiotte
Service de Médecine Intensive Réanimation, Centre Hospitalier de Valenciennes, Valenciennes, Nord-Pas de Calais, France
Julien Maizel
Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, Hauts-de-France, France
Christophe Vinsonneau
Service de Médecine Intensive Réanimation, Centre Hospitalier de Béthune, Bethune, Nord-Pas de Calais, France
Jonathan Chelly
Délégation à la Recherche Clinique et à L`innovation du GHT 83, Toulon, France
Sebastien Preau
Intensive Care Unit, CHU de Lille, Lille, Hauts-de-France, France
Ly Van Phach Vong
Marne-La-Vallee Hospital, Jossigny, Île-de-France, France
Noemie Peres
Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d`Azu, France
Ghada Sboui
Service de Médecine Intensive Réanimation, Centre Hospitalier de Béthune, Bethune, Nord-Pas de Calais, France
Marion Beuzelin
Intensive Care Unit, Centre Hospitalier de Dieppe, Dieppe, France
Olivier Nigeon
Intensive Care Unit, Centre Hospitalier de Lens, Lens, France
Thibaut Bertrand
Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d`Azu, France
Laurent Ducros
Intensive Care Unit, Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer, Toulon, Provence-Alpes-Côte d`Azu, France
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.