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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | No Intervention | normal saline | |
| low dose dexamethasone | Experimental | 0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days |
|
| high dose dexamethasone | Experimental | 0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intervention drugs would be administered for 1 or 2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28 day mortality | death at 28 day | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 90 day mortality | death at 90 day | 90 days |
| Time to septic shock | Time to septic shock after enrollment | up to 1 month, During hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyuseok Kim, M.D, PhD | Bundang CHA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang CHA hospital | Seongnam-si | Gyeonggi-do | 13488 | South Korea | ||
| Samsung Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36116775 | Derived | 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. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Time to shock reversal | time required for shock reversal | up to 1 month, During hospital stay |
| Administration of steroid according to guideline, yes or no | Need for additional steroid requirement according to the sepsis guideline | up to 1 month, During hospital stay |
| ventilator free days | days independent from ventilator care | up to 3 month, During hospital stay |
| continuous renal replacement therapy (CRRT) | requirement of CRRT | up to 3 month, During hospital stay |
| Length of stay in intensive care unit (ICU) | Days spent in intensive care unit (ICU) | up to 6 month, During hospital stay |
| Length of stay in hospital | Days spent in hospital | up to 6 month, During hospital stay |
| Delta SOFA sore on day 3 and 7 | Change of SOFA score on day 3 and day 7 | 7 days |
| Superinfection | secondary infection | 28 days |
| Gastrointestinal bleeding | Gastrointestinal bleeding at any amount | 14 days |
| Hyperglycemia | serum glucose >150 mg/dL | 7 days |
| Hypernatremia | serum sodium >150mmol/L | 7 days |
| Seoul |
| 06351 |
| South Korea |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |