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

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  • معلومة اضافية
    • Contributors:
      Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse; Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS); Aix Marseille Université (AMU); Hôpital Nord CHU - APHM; Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer; Centre Hospitalier de Béthune (CH Béthune); GHT de l'Artois; CHU Amiens-Picardie; Mécanismes physiopathologiques et conséquences des calcifications cardiovasculaires - UR UPJV 7517 (MP3CV); Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie; CHU Rouen; Normandie Université (NU); Centre hospitalier de Dieppe; Centre Hospitalier de Lens; Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Grand Hôpital de l'Est Francilien (GHEF); Hôpital Charles Nicolle Rouen; Normandie Université (NU)-Normandie Université (NU); Endothélium, valvulopathies et insuffisance cardiaque (EnVI); Université de Rouen Normandie (UNIROUEN); Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre hospitalier Valenciennes, Nord; Service de Réanimation Médicale et Toxicologique Hôpital Lariboisière; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal APHP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS); Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille)
    • بيانات النشر:
      CCSD
      BMJ Publishing Group
    • الموضوع:
      2024
    • Collection:
      Normandie Université: HAL
    • نبذة مختصرة :
      International audience ; 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 .
    • الرقم المعرف:
      10.1136/bmjopen-2024-087303
    • الدخول الالكتروني :
      https://u-picardie.hal.science/hal-04711191
      https://u-picardie.hal.science/hal-04711191v1/document
      https://u-picardie.hal.science/hal-04711191v1/file/e087303.full.pdf
      https://doi.org/10.1136/bmjopen-2024-087303
    • Rights:
      http://creativecommons.org/licenses/by-nc/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.1DF265A8