Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
- Registration Number
- NCT05136560
- Lead Sponsor
- CHA University
- 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- Sepsis defined by Sepsis-3 definition
- Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low dose dexamethasone Dexamethasone 0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days high dose dexamethasone Dexamethasone 0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days
- Primary Outcome Measures
Name Time Method 28 day mortality 28 days death at 28 day
- Secondary Outcome Measures
Name Time Method Delta SOFA sore on day 3 and 7 7 days Change of SOFA score on day 3 and day 7
Gastrointestinal bleeding 14 days Gastrointestinal bleeding at any amount
90 day mortality 90 days death at 90 day
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
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
continuous renal replacement therapy (CRRT) up to 3 month, During hospital stay requirement of CRRT
Hyperglycemia 7 days serum glucose \>150 mg/dL
Hypernatremia 7 days serum sodium \>150mmol/L
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
Superinfection 28 days secondary infection
Trial Locations
- Locations (2)
Bundang CHA hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Samsung Hospital
🇰🇷Seoul, Korea, Republic of