Clinical Trial

Assessment for Implementation Methods in Sepsis

Study acronym: AIMS
Recruiting
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Summary
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.
Trial Details
NCT Number NCT05491941
Lead Sponsor Rhode Island Hospital
Conditions Sepsis Severe, Septic Shock
Enrollment 10,000 participants
Start Date 2022-07-15
Primary Completion 2027-07-15 (estimated)
Study Completion 2027-07-15 (estimated)
Updated on ClinicalTrials.gov 2022-08-08