drugset / Trial / NCT06217939

Early Intravenous Hydrocortisone in Sepsis

NCT06217939

Recruiting 230 enrolled Siriraj Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-06-25
Primary completion
2026-06
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 200 mg Intravenous