Actively Recruiting
Assessment for Implementation Methods in Sepsis
Led by Rhode Island Hospital · Updated on 2022-08-08
10000
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment for Implementation Methods in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Patients meet criteria for sepsis within 6 hours of emergency department triage
- Infection, 2 or more systemic inflammatory response syndrome (SIRS) criteria, and at least one organ dysfunction must occur within 3 hours of each other
You will not qualify if you...
- Patients admitted previously to the same hospital for sepsis
- Pregnant women
- Transfers from another hospital
- Patients made comfort care only within 6 hours of emergency department admission
- Moribund patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
M
Mitchell Levy, MD
CONTACT
L
Lori Harmon, RRT, MBA, CPHQ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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