Sepsis
Conditions
Keywords
sepsis, glucocorticoid
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
Interventions
DRUGDexamethasone
Intervention drugs would be administered for 1 or 2 days.
Sponsors
CHA University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 * Use of etomidate in ED * pregnant or on lactation * no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28 day mortality | 28 days | death at 28 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORKyuseok Kim, M.D, PhD
Bundang CHA Hospital
Outcome results
None listed