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, Ibrahim Hassan

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Purpose: 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.

Original languageEnglish
Pages (from-to)697-701
Number of pages5
JournalShock
Volume59
Issue number5
DOIs
Publication statusPublished - 1 May 2023

Keywords

  • Ascorbic acid
  • hydrocortisone
  • septic shock
  • thiamine
  • vitamin C

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