Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHA University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

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

• recent GI bleeding, 6 weeks

• Traumatic brain injury or stroke, within 3 months

• Use of etomidate in ED

• operation, within 72 hours

• multiple trauma, within 72 hours

• severe thrombocytopenia, <30,000/mm3)

• severe chronic liver disease, Child-Pugh score C

• hemophilia

• pregnant or on lactation

• no informed consent