학술논문
Evaluation of Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Septic Shock: A Randomized Controlled Trial (The HYVITS Trial)
Document Type
Academic Journal
Author
Mohamed, Adham; Abdelaty, Mohamed; Saad, Mohamed O.; Shible, Ahmed; Mitwally, Hassan; Akkari, Abdel-Rauof; Elbuzidi, Abdurrahmaan; Bintaher, Awadh; Hashim, Ahmed; Abdelrahim, Magid; Afzal, Mohammad; El-Enany, Rasha; El-Hamid, Maha; Bakdach, Dana; Karic, Edin; Shehatta, Ahmed; Ibrahim, Abdul-Salam; Lance, Marcus; Hssain, Ali Ait; Hassan, Ibrahim
Source
Shock. Mar 09, 2023
Subject
Language
English
ISSN
1073-2322
Abstract
PURPOSE: 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 (ICUs) in Qatar. Adult patients diagnosed with septic shock requiring norepinephrine at a rate of ≥0.1 mcg/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, ICU length of stay (LOS), hospital LOS, and vasopressor duration. RESULTS: A total of 106 patients (53 in each group) were enrolled in this study. The study was terminated early owing to 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 hours.Trial RegistrationClinicalTrials.gov identifier: NCT03380507. Registered on December 21, 2017.