RecruitingNot ApplicableNCT05491941

Assessment for Implementation Methods in Sepsis

Sponsor

Rhode Island Hospital

Enrollment

10,000 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Septic Shock Sepsis, Severe

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria5

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

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Interventions

OTHERSepsis Bundle

Intervention initiated within 1 hour or 3 hours of presentation depending on the Arm: 1. Measure lactate level. 2. Obtain blood cultures before administering antibiotics. 3. Administer broad-spectrum antibiotics. 4. Begin rapid administration of 30ml/kg crystalloid for hypotension or lactate greater than or equal to 4mmol/L. 5. Apply vasopressor if hypotensive during or after fluid resuscitation to maintain a mean arterial pressure greater than or equal to 65 mm Hg.