RecruitingPhase 1Phase 2NCT05136560

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


Sponsor

CHA University

Enrollment

102 participants

Start Date

Jan 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria2

  • Sepsis defined by Sepsis-3 definition
  • Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L

Exclusion Criteria10

  • 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

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Interventions

DRUGDexamethasone

Intervention drugs would be administered for 1 or 2 days.


Locations(2)

Bundang CHA hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Hospital

Seoul, South Korea

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NCT05136560


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