Assessment for Implementation Methods in Sepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sepsis Bundle
Other interventionIntervention 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.
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Hour-1 BundleActive comparator 1 intervention
Group B: 3-Hour BundleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Mortality associated with death from sepsis.
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov