Status:
RECRUITING
Early Intravenous Hydrocortisone in Sepsis
Lead Sponsor:
Siriraj Hospital
Conditions:
Sepsis Severe
Shock, Septic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 timin...
Detailed Description
ENROLLMENT AND RANDOMIZATION Once patients meet the eligibility criteria, the treating physicians will notify one of the study investigators to invite the patients or the legal representatives to part...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06217939
Start Date
June 25 2024
End Date
September 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700