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RecruitingSepsis SevereSeptic Shock

Assessment for Implementation Methods in Sepsis

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this 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.

Sponsor: Rhode Island Hospital

You may qualify if…

  • ✓ 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.

You may not qualify if…

  • ✕ 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 recruiting

Rhode Island

Providence

Source: ClinicalTrials.gov · NCT05491941 · last updated 2022-08-08