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
1 other identifier
interventional
102
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 sepsis
Started Jan 2021
Longer than P75 for phase_1 sepsis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
November 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMay 31, 2025
May 1, 2025
5 years
November 15, 2021
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28 day mortality
death at 28 day
28 days
Secondary Outcomes (13)
90 day mortality
90 days
Time to septic shock
up to 1 month, During hospital stay
Time to shock reversal
up to 1 month, During hospital stay
Administration of steroid according to guideline, yes or no
up to 1 month, During hospital stay
ventilator free days
up to 3 month, During hospital stay
- +8 more secondary outcomes
Study Arms (3)
Placebo
NO INTERVENTIONnormal saline
low dose dexamethasone
EXPERIMENTAL0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days
high dose dexamethasone
EXPERIMENTAL0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days
Interventions
Intervention drugs would be administered for 1 or 2 days.
Eligibility Criteria
You may qualify if:
- Sepsis defined by Sepsis-3 definition
- Initial systolic blood pressure \< 90mmHg or blood lactate level \>2mmol/L
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHA Universitylead
Study Sites (2)
Bundang CHA hospital
Seongnam-si, Gyeonggi-do, 13488, South Korea
Samsung Hospital
Seoul, 06351, South Korea
Related Publications (1)
Choi K, Park JE, Kim A, Hwang S, Bae J, Shin TG, Kim K. The DEXA-SEPSIS study protocol: a phase II randomized double-blinded controlled trial of the effect of early dexamethasone in high-risk sepsis patients. Clin Exp Emerg Med. 2022 Sep;9(3):246-252. doi: 10.15441/ceem.22.276. Epub 2022 Sep 20.
PMID: 36116775DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyuseok Kim, M.D, PhD
Bundang CHA Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Emergency Department
Study Record Dates
First Submitted
November 15, 2021
First Posted
November 29, 2021
Study Start
January 15, 2021
Primary Completion
December 30, 2025
Study Completion
February 28, 2026
Last Updated
May 31, 2025
Record last verified: 2025-05