Timing of steroids could save lives in sepsis
NCT ID NCT06217939
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study looks at whether giving steroids very early to patients with severe infections and low blood pressure works better than waiting until standard treatments fail. About 230 adults will be randomly assigned to get either early steroids or a placebo, and neither they nor their doctors will know which. The main goal is to see if early treatment reduces deaths within 28 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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116 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700, Thailand
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Other studies related to the condition(s) this trial covers.
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