Clinical Trial

Early Intravenous Hydrocortisone in Sepsis

Study acronym: EARL-HYDRO
Terminated
View on ClinicalTrials.gov →
Why the trial stopped
The study was terminated early on December 25, 2025, following the Data and Safety Monitoring Board (DSMB) recommendation due to preliminary evidence of futility.
Summary
The goal of this clinical trial is to compare two timings of steroid treatment in patients with severe infection who develop low blood pressure. The main question it aims to answer is: • Which timing strategy is better between starting steroid treatment very early in the course of severe infection, or waiting until the patient does not respond to medicine that raises blood pressure according to the current guidelines? Participants will receive either early steroid treatment or placebo right after they develop low blood pressure from infection. Both participants and treating doctors will not know which treatment participants received. When blood pressure goal is not reached after a moderate dose of drugs that raise blood pressure, an open-label steroid treatment will be given to participants as indicated in the current guidelines.
Protocol Amendment History 5 changes
critical Trial terminated 2026-07-29
critical Trial terminated: The study was terminated early on December 25, 2025, following the Data and Safety Monitoring Board (DSMB) recommendati... 2026-07-29
notable Enrollment reduced: 230 -> 116 participants 2026-07-29
notable Primary completion moved earlier: 2026-06 -> 2026-01-25 2026-07-29
minor Completion moved earlier: 2026-09 -> 2026-04-25 2026-07-29
Trial Details
NCT Number NCT06217939
Lead Sponsor Siriraj Hospital
Conditions Sepsis Severe, Shock, Septic
Enrollment 116 participants
Start Date 2024-06-25
Primary Completion 2026-01-25 (estimated)
Study Completion 2026-04-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-28