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Timing of steroids could save lives in sepsis

NCT ID NCT06217939

Disease control Sponsor: Siriraj Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

116 people

The number who actually took part.

Started

Jun 2024

Finished

Apr 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

infectious disease with sepsis Sepsis Shock toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis severe Shock, septic

Contacts and locations

Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkoknoi, Bangkok, 10700, Thailand

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