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Assessment for Implementation Methods in Sepsis

Who can join

Ages 18 and older · All sexes

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

About the study

Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis "bundles" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness/implementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.

What is being tested

• Sepsis Bundle (other)

Sponsor: Rhode Island Hospital · Participants: 10,000 · Started: Jul 15, 2022

Contact the study team

• Mitchell Levy, MD · Phone: 401-444-4000
• Lori Harmon, RRT, MBA, CPHQ · Phone: 847-493-6403

Official record on ClinicalTrials.gov — NCT05491941

Locations in the U.S.

Conditions

• Sepsis
• Septic Shock

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.