3-Hour Bundle for Septic Shock

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rhode Island Hospital, Providence, RI
Septic Shock+3 More
Sepsis Bundle - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Sepsis Severe
  • Septic Shock

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Septic Shock

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 28 days

28 days
Mortality

Trial Safety

Safety Progress

1 of 3

Other trials for Septic Shock

Trial Design

2 Treatment Groups

3-Hour Bundle
1 of 2
Hour-1 Bundle
1 of 2
Active Control

10000 Total Participants · 2 Treatment Groups

Primary Treatment: 3-Hour Bundle · No Placebo Group · N/A

3-Hour Bundle
Other
ActiveComparator Group · 1 Intervention: Sepsis Bundle · Intervention Types: Other
Hour-1 Bundle
Other
ActiveComparator Group · 1 Intervention: Sepsis Bundle · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days
Closest Location: Rhode Island Hospital · Providence, RI
Photo of ri rhode island hospital 1Photo of ri rhode island hospital 2Photo of rhode island 3
2011First Recorded Clinical Trial
1 TrialsResearching Septic Shock
477 CompletedClinical Trials

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
235 Previous Clinical Trials
49,225 Total Patients Enrolled
1 Trials studying Septic Shock
113 Patients Enrolled for Septic Shock
Mitchell Levy, MDPrincipal InvestigatorRhode Island Hospital
3 Previous Clinical Trials
179 Total Patients Enrolled
1 Trials studying Septic Shock
113 Patients Enrolled for Septic Shock

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.