Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Detailed Description
The septic adult patients of high risk would be enrolled in 2 emergency departments.
Sepsis would be defined by Sepsis-3 definition. High risk is defined as initial systolic blood pressure less than 90 mmHg or blood lactate level over 2 mmol/L.
The enrolled patients would be randomized to 3 groups: control, low dose dexamethasone (0.1 mg/kg iv), and high dose dexamethasone (0.2mg/kg iv).
The study drug is blinded and administered after enrollment for 2 days. Sample size would be 102, considering 10% of drop-out rate, allocating 30 patients to each groups.
Efficacy would be evaluated as follows; 28 day and 90 day mortality, time to septic shock, time to shock reversal, administration of steroid according to guideline, ventilator free days, Continuous renal replacement, Length of stay in ICU or hospital, delta SOFA score on day 3 and day 7,
Safety would be evaluated as follows; Superinfection Gastrointestinal bleeding, Hyperglycemia, Hypernatremia
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Placebo normal saline |
|
Experimental: low dose dexamethasone 0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days |
Drug: Dexamethasone
Intervention drugs would be administered for 1 or 2 days.
Other Names:
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Experimental: high dose dexamethasone 0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days |
Drug: Dexamethasone
Intervention drugs would be administered for 1 or 2 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 28 day mortality [28 days]
death at 28 day
Secondary Outcome Measures
- 90 day mortality [90 days]
death at 90 day
- Time to septic shock [up to 1 month, During hospital stay]
Time to septic shock after enrollment
- Time to shock reversal [up to 1 month, During hospital stay]
time required for shock reversal
- Administration of steroid according to guideline, yes or no [up to 1 month, During hospital stay]
Need for additional steroid requirement according to the sepsis guideline
- ventilator free days [up to 3 month, During hospital stay]
days independent from ventilator care
- continuous renal replacement therapy (CRRT) [up to 3 month, During hospital stay]
requirement of CRRT
- Length of stay in intensive care unit (ICU) [up to 6 month, During hospital stay]
Days spent in intensive care unit (ICU)
- Length of stay in hospital [up to 6 month, During hospital stay]
Days spent in hospital
- Delta SOFA sore on day 3 and 7 [7 days]
Change of SOFA score on day 3 and day 7
- Superinfection [28 days]
secondary infection
- Gastrointestinal bleeding [14 days]
Gastrointestinal bleeding at any amount
- Hyperglycemia [7 days]
serum glucose >150 mg/dL
- Hypernatremia [7 days]
serum sodium >150mmol/L
Eligibility Criteria
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)
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recent systemic administration of chemotherapy (4 weeks)
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recent systemic administration of immunosuppressant (4 weeks)
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expected life less than 90 days
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Transferred from other hospital
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Sepsis diagnosed 24 hours after ED admission
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Use of etomidate in ED
-
pregnant or on lactation
-
no informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bundang CHA hospital | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13488 |
2 | Samsung Hospital | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- CHA University
Investigators
- Principal Investigator: Kyuseok Kim, M.D, PhD, Bundang CHA Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DEXA-SEPSIS