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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136560
• Other study ID #: DEXA-SEPSIS
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 15, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: CHA University
• Contact: Kyuseok Kim, M.D, PhD
• Phone: +82-10-4780-8321
• Email: dreinstein70[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Dexamethasone
Intervention drugs would be administered for 1 or 2 days.

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day mortality	death at 28 day	28 days
Secondary	90 day mortality	death at 90 day	90 days
Secondary	Time to septic shock	Time to septic shock after enrollment	up to 1 month, During hospital stay
Secondary	Time to shock reversal	time required for shock reversal	up to 1 month, During hospital stay
Secondary	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
Secondary	ventilator free days	days independent from ventilator care	up to 3 month, During hospital stay
Secondary	continuous renal replacement therapy (CRRT)	requirement of CRRT	up to 3 month, During hospital stay
Secondary	Length of stay in intensive care unit (ICU)	Days spent in intensive care unit (ICU)	up to 6 month, During hospital stay
Secondary	Length of stay in hospital	Days spent in hospital	up to 6 month, During hospital stay
Secondary	Delta SOFA sore on day 3 and 7	Change of SOFA score on day 3 and day 7	7 days
Secondary	Superinfection	secondary infection	28 days
Secondary	Gastrointestinal bleeding	Gastrointestinal bleeding at any amount	14 days
Secondary	Hyperglycemia	serum glucose >150 mg/dL	7 days
Secondary	Hypernatremia	serum sodium >150mmol/L	7 days