Assessment for Implementation Methods in Sepsis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sepsis Bundle

Treatment groups

10,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators