Early high-dose vitamin C in post-cardiac arrest syndrome (VITaCCA): study protocol for a randomized, double-blind, multi-center, placebo-controlled trial

Trials

卷:22

Thijs C. D. Rettig¹  Eric A. Dubois²  Evert-Jan Wils³  Arthur R. H. van Zanten⁴  Corstiaan A. den Uil⁵  Rob J. Bosman⁶  Bas van den Bogaard⁶  Sander Rozemeijer⁷  Armand R. J. Girbes⁷  Heleen M. Oudemans-van Straaten⁷  Angélique M. E. de Man⁷  Harm-Jan de Grooth⁷  Paul W. G. Elbers⁷  Roel Vink⁸ 

[1] Department of Anesthesiology, Intensive Care and Pain Medicine, Amphia Hospital;

[2] Department of Cardiology, Erasmus University Medical Center;

[3] Department of Intensive Care Medicine, Franciscus Gasthuis & Vlietland;

[4] Department of Intensive Care Medicine, Gelderse Vallei Hospital;

[5] Department of Intensive Care Medicine, Maasstad Hospital;

[6] Department of Intensive Care Medicine, OLVG;

[7] Department of Intensive Care Medicine, Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam Medical Data Science (AMDS), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam;

[8] Department of Intensive Care Medicine, Tergooi Hospital;

关键词: Out-of-hospital cardiac arrest;    Ischemia/reperfusion injury;    Post-cardiac arrest syndrome;    Cardiac arrest;    Free radicals;    Reactive oxygen species;   

DOI  :  10.1186/s13063-021-05483-3

来源: DOAJ

【 摘 要 】

Abstract Background High-dose intravenous vitamin C directly scavenges and decreases the production of harmful reactive oxygen species (ROS) generated during ischemia/reperfusion after a cardiac arrest. The aim of this study is to investigate whether short-term treatment with a supplementary or very high-dose intravenous vitamin C reduces organ failure in post-cardiac arrest patients. Methods This is a double-blind, multi-center, randomized placebo-controlled trial conducted in 7 intensive care units (ICUs) in The Netherlands. A total of 270 patients with cardiac arrest and return of spontaneous circulation will be randomly assigned to three groups of 90 patients (1:1:1 ratio, stratified by site and age). Patients will intravenously receive a placebo, a supplementation dose of 3 g of vitamin C or a pharmacological dose of 10 g of vitamin C per day for 96 h. The primary endpoint is organ failure at 96 h as measured by the Resuscitation-Sequential Organ Failure Assessment (R-SOFA) score at 96 h minus the baseline score (delta R-SOFA). Secondary endpoints are a neurological outcome, mortality, length of ICU and hospital stay, myocardial injury, vasopressor support, lung injury score, ventilator-free days, renal function, ICU-acquired weakness, delirium, oxidative stress parameters, and plasma vitamin C concentrations. Discussion Vitamin C supplementation is safe and preclinical studies have shown beneficial effects of high-dose IV vitamin C in cardiac arrest models. This is the first RCT to assess the clinical effect of intravenous vitamin C on organ dysfunction in critically ill patients after cardiac arrest. Trial registration ClinicalTrials.gov NCT03509662. Registered on April 26, 2018. https://clinicaltrials.gov/ct2/show/NCT03509662 European Clinical Trials Database (EudraCT): 2017-004318-25. Registered on June 8, 2018. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004318-25/NL

【 授权许可】

Unknown