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

Abstract

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.

Keywords: Death, Sudden, Cardiac; INTENSIVE & CRITICAL CARE; Out-of-Hospital Cardiac Arrest.

Figure 1. Flow chart of the vitamin C efficacy on postcardiac arrest shock study protocol. ICU, intensive care unit; OHCA, out-of-hospital cardiac arrest; ROSC, return of spontaneous circulation; Vit-C, vitamin C.

Figure 2. Experimental plan of the vitamin C efficacy on postcardiac arrest shock study protocol. ICU, intensive care unit; mRS, modified Rankin Scale; OHCA, out-of-hospital cardiac arrest; ROSC, return of spontaneous circulation; SOFA, sequential organ failure assessment score; Vit-C, vitamin C.

Figure 3. Decision algorithm for haemodynamic management. MAP, mean arterial pressure; *for patients under epinephrine and norepinephrine simultaneously, it is suggested to wean epinephrine first.