Early Intravenous Hydrocortisone in Sepsis

Launched by SIRIRAJ HOSPITAL · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the best timing for steroid treatment in patients with severe infections, known as sepsis, who experience low blood pressure. Researchers want to find out if giving steroids right away when a patient shows signs of low blood pressure is more effective than waiting until the patient does not respond to standard medications that help raise blood pressure. Participants will either receive early steroid treatment or a placebo (a treatment that looks like the real one but has no active medication) immediately after developing low blood pressure. Neither the patients nor their doctors will know which treatment is being given.

To be eligible for this study, participants must be at least 18 years old and have suspected or confirmed sepsis with a low blood pressure reading. Certain individuals, such as those with other causes of shock, pregnant women, or those who have recently received specific treatments or medications, will not be able to join the trial. Participants can expect to be monitored closely, and if their blood pressure does not improve after receiving a moderate dose of blood pressure-raising medication, they will receive steroids according to current guidelines. This trial is currently recruiting and aims to improve treatment options for patients with severe infections.

Gender

ALL

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