Comparing early hydrocortisone treatment for severe sepsis

Early Intravenous Hydrocortisone in Sepsis: a Randomized Control Trial

This study is testing if giving hydrocortisone right away helps people with severe sepsis and low blood pressure feel better compared to waiting until other treatments don't work.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Siriraj Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bangkoknoi, Bangkok)
• Trial ID: NCT06217939 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of early intravenous hydrocortisone treatment in patients experiencing severe sepsis and low blood pressure. Participants will be randomly assigned to receive either early hydrocortisone or a placebo immediately after developing hypotension due to infection. The study will assess which timing of steroid administration is more beneficial, comparing early treatment against the standard approach of waiting until other medications fail to stabilize blood pressure. Both participants and healthcare providers will be blinded to the treatment assignments to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older who are diagnosed with severe sepsis and exhibit low blood pressure.

Not a fit: Patients who are immunocompromised or have causes of shock other than sepsis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for patients with severe sepsis by establishing a more effective treatment protocol.

How similar studies have performed: Previous studies have explored steroid treatments in sepsis, but this specific timing strategy is novel and has not been extensively tested.

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

Where this trial is running

Bangkoknoi, Bangkok

• Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkoknoi, Bangkok, Thailand (RECRUITING)

Study contacts

• Principal investigator: Chairat Permpikul, MD — Mahidol University
• Study coordinator: Wasin Pansiritanachot, MD

Conditions: Sepsis Severe, Shock, Septic, sepsis, hydrocortisone, shock, early