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Search / Trial NCT05136560

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

Launched by CHA UNIVERSITY · Nov 15, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Sepsis, Glucocorticoid

ClinConnect Summary

This clinical trial is looking at how safe and effective it is to give a medication called dexamethasone to patients who are at high risk for sepsis, a serious condition caused by infection. The study will test two different doses of dexamethasone to see which one works better when given early in the treatment process. Sepsis can cause low blood pressure and other serious symptoms, so the goal is to find a way to help these patients recover more quickly.

To be eligible for this trial, participants need to have sepsis, which is defined by specific medical criteria, and show signs of severe illness, like very low blood pressure or high levels of certain substances in the blood. Unfortunately, some people won't be able to participate, including those who have certain medical conditions or treatments, such as recent use of specific medications like chemotherapy or immunosuppressants. If enrolled in the trial, participants will receive either of the two doses of dexamethasone, and doctors will closely monitor their health to ensure safety throughout the study. This research is important because it could help improve treatment options for patients with sepsis in the future.

Gender

ALL

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

About Cha University

CHA University is a leading research institution dedicated to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on collaboration and interdisciplinary approaches, CHA University engages in cutting-edge research across various fields, including oncology, cardiology, and regenerative medicine. The university fosters a dynamic environment for clinical research, driven by a commitment to ethical standards and patient safety, ensuring that all trials are conducted with the highest level of scientific rigor. Through its extensive network of healthcare professionals and state-of-the-art facilities, CHA University aims to contribute significantly to the development of new therapies and enhance the understanding of complex medical conditions.

Locations

Seongnam Si, Gyeonggi Do, Korea, Republic Of

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Kyuseok Kim, M.D, PhD

Principal Investigator

Bundang CHA Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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