A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Who is this study for? Patients with Sepsis
What treatments are being studied? Dexamethasone
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Sepsis defined by Sepsis-3 definition
• Initial systolic blood pressure \< 90mmHg or blood lactate level \>2mmol/L
Locations
Other Locations
Republic of Korea
Bundang CHA hospital
RECRUITING
Seongnam-si
Samsung Hospital
RECRUITING
Seoul
Contact Information
Primary
Kyuseok Kim, M.D, PhD
dreinstein70@gmail.com
+82-10-4780-8321
Time Frame
Start Date: 2021-01-15
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 102
Treatments
No_intervention: Placebo
normal saline
Experimental: low dose dexamethasone
0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days
Experimental: high dose dexamethasone
0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days
Related Therapeutic Areas
Sponsors
Leads: CHA University