• Shock · May 2023

    Randomized Controlled Trial Multicenter Study

    Evaluation of Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Septic Shock: A Randomized Controlled Trial (The HYVITS Trial).

    • Adham Mohamed, Mohamed Abdelaty, Mohamed O Saad, Ahmed Shible, Hassan Mitwally, Abdel-Rauof Akkari, Abdurrahmaan Elbuzidi, Awadh Bintaher, Ahmed Hashim, Magid Abdelrahim, Mohammad Afzal, Rasha El-Enany, Maha El-Hamid, Dana Bakdach, Edin Karic, Ahmed Shehatta, Abdul-Salam Ibrahim, Marcus Lance, Ali Ait Hssain, and Ibrahim Hassan.
    • Saint Luke's Hospital of Kansas City, Kansas City, Missouri.
    • Shock. 2023 May 1; 59 (5): 697701697-701.

    AbstractPurpose: The aim of the study is to evaluate the effect of combined hydrocortisone, vitamin C, and thiamine (triple therapy) on the mortality of patients with septic shock. Methods : This multicenter, open-label, two-arm parallel-group, randomized controlled trial was conducted in four intensive care units in Qatar. Adult patients diagnosed with septic shock requiring norepinephrine at a rate of ≥0.1 μg/kg/min for ≥6 h were randomized to a triple therapy group or a control group. The primary outcome was in-hospital mortality at 60 days or at discharge, whichever occurred first. Secondary outcomes included time to death, change in Sequential Organ Failure Assessment (SOFA) score at 72 h of randomization, intensive care unit length of stay, hospital length of stay, and vasopressor duration. Results: A total of 106 patients (53 in each group) were enrolled in this study. The study was terminated early because of a lack of funding. The median baseline SOFA score was 10 (interquartile range, 8-12). The primary outcomes were similar between the two groups (triple therapy, 28.3% vs. control, 35.8%; P = 0.41). Vasopressor duration among the survivors was similar between the two groups (triple therapy, 50 h vs. control, 58 h; P = 0.44). Other secondary and safety endpoints were similar between the two groups. Conclusion: Triple therapy did not improve in-hospital mortality at 60 days in critically ill patients with septic shock or reduce the vasopressor duration or SOFA score at 72 h. Trial Registration:ClinicalTrials.gov identifier: NCT03380507. Registered on December 21, 2017.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Shock Society.

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