Multi-marker INDex for the Risk Assessment of Sepsis in the Emergency departmenT (MINDSET)
NCT ID: NCT00472628
Last Updated: 2015-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2007-05-31
2007-08-31
Brief Summary
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Detailed Description
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The day of enrollment is defined as Study Day 0. Enrolled patients who are discharged to home will be contacted by telephone on Study Days 3, 14 and 28 to assess their clinical status.
Patients who are admitted to the hospital following initial enrollment will undergo the following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the hospital and alive at these time points).
Each patient will also be contacted on Study Day 14 and on or after Study Day 28 to assess the duration of hospital stay and mortality through Days 14 and 28.
Conditions
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Study Design
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PROSPECTIVE
Interventions
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Blood samples collected
Eligibility Criteria
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Inclusion Criteria
* Presenting to the emergency department (ED) for evaluation and who can be enrolled within 6 hours of initial ED evaluation
* Exhibiting two or more of any diagnostic criteria for sepsis
* Willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on Study Days 3, 14, and 28
Exclusion Criteria
* Participation in any interventional clinical study within the previous 30 days
* Status-post cardiac arrest (within the past month)
* Moribund or with active "Do Not Resuscitate" or "Comfort Care Only" status
* Prisoners or other institutionalized or vulnerable individuals
* Already a hospital in-patient
* Unwilling or unlikely to comply with study procedures or to be reachable by telephone (or in person) for Day 3, 14, and 28 status assessments if discharged
18 Years
ALL
No
Sponsors
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Abbott RDx Cardiometabolic
OTHER
Principal Investigators
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Emanuel Rivers, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Mitchell Levy, MD
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Locations
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LA County/ USC
Los Angeles, California, United States
Olive View Medical Center - UCLA
Sylmar, California, United States
Denver Health
Denver, Colorado, United States
George Washington University
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Bay State Medical Center
Springfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Wayne State - Detroit Receiving Hospital
Detroit, Michigan, United States
Cooper Health
Camden, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
SUNY Stony Brook
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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Study Closed 9/13/07
Identifier Type: -
Identifier Source: secondary_id
BSTE-0501 - CLOSED
Identifier Type: -
Identifier Source: org_study_id
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