Sepsis Bundle Implementation Study

This study is looking at the best way to treat severe sepsis and septic shock, which are serious conditions caused by the body's overwhelming response to an infection. Researchers are comparing two different approaches to delivering a "sepsis bundle" – a set of treatments that includes measuring lactate levels, taking blood cultures, and giving broad-spectrum antibiotics. One approach delivers these treatments within 1 hour, and the other within 3 hours. The goal is to see which method leads to better survival rates for patients. This study will enroll up to 10,000 adults aged 18 and older who meet specific criteria for sepsis upon arrival at the emergency department. The main way to measure success is by looking at mortality (death) rates 28 days after treatment.

Study design
This is an interventional study comparing two different treatment approaches for sepsis, with a planned enrollment of 10,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' mortality will be measured at 28 days after treatment.

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NCT05491941

Assessment for Implementation Methods in Sepsis

Recruiting
NAAges 18+InterventionalTreatment
Rhode Island Hospital
~10,000 participants
Updated 2022-08-08 on ClinicalTrials.gov
What's tested:Sepsis Bundle

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mortality
Measured over 28 days
Sepsis Severe
Septic Shock
1 sites across 1 states
Rhode Island1
  • Mitchell Levy, MD · PRINCIPAL_INVESTIGATOR · Rhode Island Hospital

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Eligibility criteria

Inclusion

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

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
  • Mortality28 days

    Mortality associated with death from sepsis.