RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
About This Trial
The purpose of this study is to investigate the safety and efficacy of early administration of two different doses of dexamethasone in high risk septic patients.
Who May Be Eligible (Plain English)
Who May Qualify:
- Sepsis defined by Sepsis-3 definition
- Initial systolic blood pressure \< 90mmHg or blood lactate level \>2mmol/L
Who Should NOT Join This Trial:
- advanced directive for "Do not resuscitation"
- recent systemic administration of glucocorticoid (4 weeks)
- recent systemic administration of chemotherapy (4 weeks)
- recent systemic administration of immunosuppressant (4 weeks)
- expected life less than 90 days
- Transferred from other hospital
- Sepsis diagnosed 24 hours after ED admission
- Use of etomidate in ED
- pregnant or on lactation
- no willing to sign a consent form
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Sepsis defined by Sepsis-3 definition
* Initial systolic blood pressure \< 90mmHg or blood lactate level \>2mmol/L
Exclusion Criteria:
* advanced directive for "Do not resuscitation"
* recent systemic administration of glucocorticoid (4 weeks)
* recent systemic administration of chemotherapy (4 weeks)
* recent systemic administration of immunosuppressant (4 weeks)
* expected life less than 90 days
* Transferred from other hospital
* Sepsis diagnosed 24 hours after ED admission
* Use of etomidate in ED
* pregnant or on lactation
* no informed consent
Treatments Being Tested
DRUG
Dexamethasone
Intervention drugs would be administered for 1 or 2 days.
Locations (2)
Bundang CHA hospital
Seongnam-si, Gyeonggi-do, South Korea
Samsung Hospital
Seoul, South Korea