Investigating early dexamethasone treatment for high-risk sepsis patients
A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
PHASE1; PHASE2 · CHA University · NCT05136560
This study is testing whether giving different doses of dexamethasone early can help high-risk adults with sepsis feel better and improve their chances of survival.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seongnam-si, Gyeonggi-do and 1 other locations) |
| Trial ID | NCT05136560 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of early administration of two different doses of dexamethasone in adult patients at high risk for sepsis, defined by specific clinical criteria. Patients will be randomized into three groups: a control group and two treatment groups receiving low and high doses of dexamethasone. The study will assess various outcomes, including mortality rates at 28 and 90 days, time to septic shock, and safety measures such as the incidence of superinfection and hyperglycemia. A total of 102 patients will be enrolled across two emergency departments, with a follow-up period to monitor the effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients diagnosed with sepsis who exhibit low blood pressure or elevated lactate levels.
Not a fit: Patients with advanced directives for 'Do not resuscitate', recent glucocorticoid use, or those with a life expectancy of less than 90 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and better management of high-risk sepsis patients through early dexamethasone administration.
How similar studies have performed: Previous studies have shown varying results with glucocorticoid treatments in sepsis, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seongnam-si, Gyeonggi-do and 1 other locations
- Bundang CHA hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
- Samsung Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Kyuseok Kim, M.D, PhD — Bundang CHA Hospital
- Study coordinator: Kyuseok Kim, M.D, PhD
- Email: dreinstein70@gmail.com
- Phone: +82-10-4780-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, sepsis, glucocorticoid