Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Phase 1
Recruiting
- Conditions
- Sepsis
- Registration Number
- NCT05136560
- Lead Sponsor
- CHA University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Sepsis defined by Sepsis-3 definition<br><br> - Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L<br><br>Exclusion Criteria:<br><br> - advanced directive for Do not resuscitation<br><br> - recent systemic administration of glucocorticoid (4 weeks)<br><br> - recent systemic administration of chemotherapy (4 weeks)<br><br> - recent systemic administration of immunosuppressant (4 weeks)<br><br> - expected life less than 90 days<br><br> - Transferred from other hospital<br><br> - Sepsis diagnosed 24 hours after ED admission<br><br> - Use of etomidate in ED<br><br> - pregnant or on lactation<br><br> - no informed consent
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28 day mortality
- Secondary Outcome Measures
Name Time Method 90 day mortality;Time to septic shock;Time to shock reversal;Administration of steroid according to guideline, yes or no;ventilator free days;continuous renal replacement therapy (CRRT);Length of stay in intensive care unit (ICU);Length of stay in hospital;Delta SOFA sore on day 3 and 7;Superinfection;Gastrointestinal bleeding;Hyperglycemia;Hypernatremia