Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

normal saline

Group Type NO_INTERVENTION

No interventions assigned to this group

low dose dexamethasone

0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Intervention drugs would be administered for 1 or 2 days.

high dose dexamethasone

0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Intervention drugs would be administered for 1 or 2 days.

Interventions

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Dexamethasone

Intervention drugs would be administered for 1 or 2 days.

Intervention Type DRUG

Other Intervention Names

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JEIL Dexamethasone Injection

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No