Clinical trial NCT05136560: Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Official title: A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Sepsis
Keywords: sepsis, glucocorticoid
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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)
* 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

Primary outcomes:
measure: 28 day mortality
timeFrame: 28 days
Secondary outcomes:
measure: 90 day mortality
timeFrame: 90 days
measure: Time to septic shock
timeFrame: up to 1 month, During hospital stay
measure: Time to shock reversal
timeFrame: up to 1 month, During hospital stay
measure: Administration of steroid according to guideline, yes or no
timeFrame: up to 1 month, During hospital stay
measure: ventilator free days
timeFrame: up to 3 month, During hospital stay
measure: continuous renal replacement therapy (CRRT)
timeFrame: up to 3 month, During hospital stay
measure: Length of stay in intensive care unit (ICU)
timeFrame: up to 6 month, During hospital stay
measure: Length of stay in hospital
timeFrame: up to 6 month, During hospital stay
measure: Delta SOFA sore on day 3 and 7
timeFrame: 7 days
measure: Superinfection
timeFrame: 28 days
measure: Gastrointestinal bleeding
timeFrame: 14 days
measure: Hyperglycemia
timeFrame: 7 days
measure: Hypernatremia
timeFrame: 7 days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Hospital
Study officials:
affiliation: Bundang CHA Hospital
name: Kyuseok Kim, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.