Multi-marker INDex for the Risk Assessment of Sepsis in the Emergency departmenT (MINDSET)

NCT ID: NCT00472628

Last Updated: 2015-07-21

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.

Detailed Description

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This is a multi-center, prospective specimen procurement study. The samples will be used for future testing of the Triage Sepsis Panel in conjunction with other laboratory tests and clinical assessments as an aid in the assessment for risk of sepsis progression within 72 hours of patients presenting in the Emergency Department and meeting the diagnostic criteria for sepsis who might be considered for hospital admission, including to the ICU. Approximately 700 patients presenting to the Emergency Department (ED) with at least two of the symptoms or signs of sepsis will be enrolled in this study.

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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Sepsis

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Blood samples collected

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female 18 years of age or older
* 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

* Age \< 18 years
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott RDx Cardiometabolic

OTHER

Sponsor Role lead

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

Site Status

Olive View Medical Center - UCLA

Sylmar, California, United States

Site Status

Denver Health

Denver, Colorado, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Bay State Medical Center

Springfield, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Wayne State - Detroit Receiving Hospital

Detroit, Michigan, United States

Site Status

Cooper Health

Camden, New Jersey, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Staten Island University Hospital

Staten Island, New York, United States

Site Status

SUNY Stony Brook

Stony Brook, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

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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