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

A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: Dexamethasone

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Samsung Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13488
      • Bundang CHA hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo; normal saline
Experimental: low dose dexamethasone; 0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days	Drug: Dexamethasone; Intervention drugs would be administered for 1 or 2 days.; Other Names: JEIL Dexamethasone Injection
Experimental: high dose dexamethasone; 0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days	Drug: Dexamethasone; Intervention drugs would be administered for 1 or 2 days.; Other Names: JEIL Dexamethasone Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	death at 28 day	28 days

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: CHA University
• Investigators: Principal Investigator: Kyuseok Kim, M.D, PhD, Bundang CHA hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sepsis, glucocorticoid
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: DEXA-SEPSIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No