SepsisPhase 1/2NCT05136560
Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
A Phase 1/2 study testing Dexamethasone in people with Sepsis, run by CHA University at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Mar 2022to 28 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis defined by Sepsis-3 definition
- Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L
Who cannot join
- 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
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- Sepsis diagnosed 24 hours after ED admission
- Use of etomidate in ED
- pregnant or on lactation
- no informed consent
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Bundang CHA hospital
Seongnam-si, Gyeonggi-do, 13488
Samsung Hospital
Seoul, 06351
About this study
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
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.
Read the 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
- Conditions
- Sepsis
- Being tested
- Dexamethasone
- Keywords
- sepsis, glucocorticoid
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called JEIL Dexamethasone Injection
Intervention drugs would be administered for 1 or 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | normal saline |
| low dose dexamethasone | Experimental | 0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days Receives: Drug: Dexamethasone |
| high dose dexamethasone | Experimental | 0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
death at 28 day
Measured: 28 days
Secondary outcomes (13)
90 day mortality
death at 90 day
Measured: 90 days
Time to septic shock
Time to septic shock after enrollment
Measured: up to 1 month, During hospital stay
Time to shock reversal
time required for shock reversal
Measured: 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
Measured: up to 1 month, During hospital stay
ventilator free days
days independent from ventilator care
Measured: up to 3 month, During hospital stay
continuous renal replacement therapy (CRRT)
requirement of CRRT
Measured: up to 3 month, During hospital stay
Length of stay in intensive care unit (ICU)
Days spent in intensive care unit (ICU)
Measured: up to 6 month, During hospital stay
Length of stay in hospital
Days spent in hospital
Measured: 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
Measured: 7 days
Superinfection
secondary infection
Measured: 28 days
Gastrointestinal bleeding
Gastrointestinal bleeding at any amount
Measured: 14 days
Hyperglycemia
serum glucose >150 mg/dL
Measured: 7 days
Hypernatremia
serum sodium >150mmol/L
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Mar 2022
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyuseok Kim, CHA University
- Investigators
- Kyuseok Kim, M.D, PhD, Principal investigator, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136560
- Sponsor's protocol ID
- DEXA-SEPSIS
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36116775
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05136560
- Acronym / sponsor ID
- DEXA-SEPSIS
- Conditions
- Sepsis
- Keywords
- sepsis, glucocorticoid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –normal saline |
| low dose dexamethasone | Experimental | Drug: Dexamethasone0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days |
| high dose dexamethasone | Experimental | Drug: Dexamethasone0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sepsis defined by Sepsis-3 definition
- Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: JEIL Dexamethasone InjectionIntervention drugs would be administered for 1 or 2 days. | Drug | high dose dexamethasone, low dose dexamethasone |
Primary outcome
28 day mortality
Time frame: 28 days
death at 28 day
13 secondary outcomes
90 day mortality
Time frame: 90 days
Time to septic shock
Time frame: up to 1 month, During hospital stay
Time to shock reversal
Time frame: up to 1 month, During hospital stay
Administration of steroid according to guideline, yes or no
Time frame: up to 1 month, During hospital stay
ventilator free days
Time frame: up to 3 month, During hospital stay
continuous renal replacement therapy (CRRT)
Time frame: up to 3 month, During hospital stay
Length of stay in intensive care unit (ICU)
Time frame: up to 6 month, During hospital stay
Length of stay in hospital
Time frame: up to 6 month, During hospital stay
Delta SOFA sore on day 3 and 7
Time frame: 7 days
Superinfection
Time frame: 28 days
Gastrointestinal bleeding
Time frame: 14 days
Hyperglycemia
Time frame: 7 days
Hypernatremia
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 36116775Choi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyuseok Kim, M.D, PhD principal investigator
Bundang CHA Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone in people with Sepsis, run by CHA University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.