Back to resultsSafety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Primary Purpose
Sepsis
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring sepsis, glucocorticoid
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
Sites / Locations
- Bundang CHA hospitalRecruiting
- Samsung HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Placebo
low dose dexamethasone
high dose dexamethasone
Arm Description
normal saline
0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days
0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days
Outcomes
Primary Outcome Measures
28 day mortality
death at 28 day
Secondary Outcome Measures
90 day mortality
death at 90 day
Time to septic shock
Time to septic shock after enrollment
Time to shock reversal
time required for shock reversal
Administration of steroid according to guideline, yes or no
Need for additional steroid requirement according to the sepsis guideline
ventilator free days
days independent from ventilator care
continuous renal replacement therapy (CRRT)
requirement of CRRT
Length of stay in intensive care unit (ICU)
Days spent in intensive care unit (ICU)
Length of stay in hospital
Days spent in hospital
Delta SOFA sore on day 3 and 7
Change of SOFA score on day 3 and day 7
Superinfection
secondary infection
Gastrointestinal bleeding
Gastrointestinal bleeding at any amount
Hyperglycemia
serum glucose >150 mg/dL
Hypernatremia
serum sodium >150mmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05136560
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis, glucocorticoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
normal saline
Arm Title
low dose dexamethasone
Arm Type
Experimental
Arm Description
0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days
Arm Title
high dose dexamethasone
Arm Type
Experimental
Arm Description
0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
JEIL Dexamethasone Injection
Intervention Description
Intervention drugs would be administered for 1 or 2 days.
Primary Outcome Measure Information:
Title
28 day mortality
Description
death at 28 day
Time Frame
28 days
Secondary Outcome Measure Information:
Title
90 day mortality
Description
death at 90 day
Time Frame
90 days
Title
Time to septic shock
Description
Time to septic shock after enrollment
Time Frame
up to 1 month, During hospital stay
Title
Time to shock reversal
Description
time required for shock reversal
Time Frame
up to 1 month, During hospital stay
Title
Administration of steroid according to guideline, yes or no
Description
Need for additional steroid requirement according to the sepsis guideline
Time Frame
up to 1 month, During hospital stay
Title
ventilator free days
Description
days independent from ventilator care
Time Frame
up to 3 month, During hospital stay
Title
continuous renal replacement therapy (CRRT)
Description
requirement of CRRT
Time Frame
up to 3 month, During hospital stay
Title
Length of stay in intensive care unit (ICU)
Description
Days spent in intensive care unit (ICU)
Time Frame
up to 6 month, During hospital stay
Title
Length of stay in hospital
Description
Days spent in hospital
Time Frame
up to 6 month, During hospital stay
Title
Delta SOFA sore on day 3 and 7
Description
Change of SOFA score on day 3 and day 7
Time Frame
7 days
Title
Superinfection
Description
secondary infection
Time Frame
28 days
Title
Gastrointestinal bleeding
Description
Gastrointestinal bleeding at any amount
Time Frame
14 days
Title
Hyperglycemia
Description
serum glucose >150 mg/dL
Time Frame
7 days
Title
Hypernatremia
Description
serum sodium >150mmol/L
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyuseok Kim, M.D, PhD
Phone
+82-10-4780-8321
Email
dreinstein70@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, M.D, PhD
Organizational Affiliation
Bundang CHA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang CHA hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13488
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, M.D, PhD
Phone
+821047808321
Email
dreinstein70@gmail.com
Facility Name
Samsung Hospital
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Gun Shin, M.D, PhD
Phone
+821099445806
Email
taegunshin@skku.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36116775
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.
Results Reference
derived
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Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
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