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

Sponsor
CHA University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05136560
Collaborator
(none)
102
2
3
20.5
51
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 28 day mortality [28 days]

      death at 28 day

    Secondary Outcome Measures

    1. 90 day mortality [90 days]

      death at 90 day

    2. Time to septic shock [up to 1 month, During hospital stay]

      Time to septic shock after enrollment

    3. Time to shock reversal [up to 1 month, During hospital stay]

      time required for shock reversal

    4. Administration of steroid according to guideline, yes or no [up to 1 month, During hospital stay]

      Need for additional steroid requirement according to the sepsis guideline

    5. ventilator free days [up to 3 month, During hospital stay]

      days independent from ventilator care

    6. continuous renal replacement therapy (CRRT) [up to 3 month, During hospital stay]

      requirement of CRRT

    7. Length of stay in intensive care unit (ICU) [up to 6 month, During hospital stay]

      Days spent in intensive care unit (ICU)

    8. Length of stay in hospital [up to 6 month, During hospital stay]

      Days spent in hospital

    9. Delta SOFA sore on day 3 and 7 [7 days]

      Change of SOFA score on day 3 and day 7

    10. Superinfection [28 days]

      secondary infection

    11. Gastrointestinal bleeding [14 days]

      Gastrointestinal bleeding at any amount

    12. Hyperglycemia [7 days]

      serum glucose >150 mg/dL

    13. Hypernatremia [7 days]

      serum sodium >150mmol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bundang CHA hospital Seongnam-si Gyeonggi-do Korea, Republic of 13488
    2 Samsung Hospital Seoul Korea, Republic of 06351

    Sponsors and Collaborators

    • CHA University

    Investigators

    • Principal Investigator: Kyuseok Kim, M.D, PhD, Bundang CHA Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyuseok Kim, Professor, Emergency Department, CHA University
    ClinicalTrials.gov Identifier:
    NCT05136560
    Other Study ID Numbers:
    • DEXA-SEPSIS
    First Posted:
    Nov 29, 2021
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Kyuseok Kim, Professor, Emergency Department, CHA University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2022