Evaluating sepsis treatment methods in emergency departments
Assessment for Implementation Methods in Sepsis
NA · Rhode Island Hospital · NCT05491941
This study tests two different treatment plans for sepsis in emergency rooms to see which one helps patients survive and avoid breathing problems better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05491941 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of two sepsis treatment bundles, the Hour-1 and 3-hour bundles, in patients admitted to the emergency department with sepsis. It is a pragmatic, cluster randomized trial that aims to compare mortality and respiratory failure outcomes while facilitating adherence to both treatment protocols. Additionally, the study will derive four distinct sepsis phenotypes from routine clinical data to enhance the precision of future sepsis bundle applications. The trial addresses the urgent need for improved sepsis management in critical care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with sepsis within 6 hours of emergency department triage.
Not a fit: Patients who are pregnant, those admitted for comfort care only, or moribund patients will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced respiratory failure in sepsis patients.
How similar studies have performed: Previous studies have shown success with sepsis bundles, indicating a strong potential for this approach to improve patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults \>=18 * Patient meets criteria for time zero (sepsis within 6 hours of ED triage and the 3 criteria-infection, 2 SIRS and 1 or more organ dysfunctions, must be met within 3 hours of each other. Exclusion Criteria: * Last admission for patients admitted to same hospital once * Pregnant women * All transfers from another hospital * Individuals who are made comfort care only within 6 hours of admission to ED * Moribund patients
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Mitchell Levy, MD — Rhode Island Hospital
- Study coordinator: Mitchell Levy, MD
- Email: mitchell_levy@brown.edu
- Phone: 401-444-4000
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 Severe, Septic Shock