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Assessment for Implementation Methods in Sepsis
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.
Conditions:
🦠 Sepsis Severe 🦠 Septic Shock
🗓️ Study Start (Actual) 15 July 2022
🗓️ Primary Completion (Estimated) 15 July 2027
✅ Study Completion (Estimated) 15 July 2027
👥 Enrollment (Estimated) 10000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Providence, Rhode Island, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 August 2022
  • First Submitted that Met QC Criteria 4 August 2022
  • First Posted 8 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 August 2022
  • Last Update Posted 8 August 2022
  • Last Verified August 2022
I'm interested ...!!