Early Intravenous Hydrocortisone in Sepsis
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
| Condition(s) | Sepsis Severe, Shock, Septic |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 participant |
| Who can participate | 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 in |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Siriraj Hospital |
| Locations | Bangkoknoi, Bangkok, Thailand |
| Start date | 2024-06-25 |
| NCT ID | NCT06217939 |
| Official listing | https://clinicaltrials.gov/study/NCT06217939 |