Actively Recruiting
Early Intravenous Hydrocortisone in Sepsis
Led by Siriraj Hospital · Updated on 2026-01-07
230
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Intravenous Hydrocortisone in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Suspected or definite sepsis Sepsis is defined by SEPSIS-3 definition as Sequential Organ Failure Assessment (SOFA) score ≥ 2 from baseline with suspected infection.2 Suspected sepsis is defined as patients with suspected infection who meet 2 or more criteria of quick SOFA (altered mentation, respiratory rate ≥ 22/min, systolic blood pressure ≤ 100 mmHg).
- Hypotension (mean arterial pressure < 65 mmHg)
You will not qualify if you...
- Randomization and administration of the study drugs are not able to be executed within 3 hours after the onset of hypotension
- Causes of shock other than sepsis identified
- Immunocompromised A patient is considered immunocompromised if one of the following criteria is met: history of human immunodeficiency virus infection or acquired immunodeficiency syndrome, hematologic malignancy, receiving chemotherapy, active cancer receiving chemotherapy, current use of immunosuppressive medication)
- Hyperglycemic crisis (diabetic ketoacidosis, hyperosmolar hyperglycemic state)
- Pregnancy
- Post-cardiac arrest
- Received etomidate before randomization
- Systemic corticosteroids indicated for other conditions
- Received systemic corticosteroids within 4 weeks at any dose
- Cancer patients who are receiving palliative treatment
- Do-not-resuscitate order
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Actively Recruiting
Research Team
W
Wasin Pansiritanachot, MD
CONTACT
C
Chairat Permpikul, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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