NCT06217939 Early Intravenous Hydrocortisone in Sepsis
| NCT ID | NCT06217939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Siriraj Hospital |
| Condition | Sepsis Severe |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2024-06-25 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Chairat Permpikul, MD
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT06217939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis Severe. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06217939 currently recruiting?
Yes, NCT06217939 is actively recruiting participants. Contact the research team at dr.wasinpan@gmail.com for enrollment information.
Where is the NCT06217939 trial being conducted?
This trial is being conducted at Bangkoknoi, Thailand.
Who is sponsoring the NCT06217939 clinical trial?
NCT06217939 is sponsored by Siriraj Hospital. The principal investigator is Chairat Permpikul, MD at Mahidol University. The trial plans to enroll 230 participants.