RecruitingPhase 1Phase 2NCT05136560
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
Sponsor
CHA University
Enrollment
102 participants
Start Date
Jan 15, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 19 Years
Inclusion Criteria2
- Sepsis defined by Sepsis-3 definition
- Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L
Exclusion Criteria10
- 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
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Interventions
DRUGDexamethasone
Intervention drugs would be administered for 1 or 2 days.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05136560
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