Evaluating sepsis treatment methods in emergency departments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.