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

Sponsor
Biosite (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00472628
Collaborator
(none)
0
Enrollment
24
Locations
3
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood samples collected

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Time Perspective:
Prospective
Official Title:
Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department
Study Start Date :
May 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LA County/ USC Los Angeles California United States
    2 Olive View Medical Center - UCLA Sylmar California United States
    3 Denver Health Denver Colorado United States
    4 George Washington University Washington District of Columbia United States
    5 Emory University Atlanta Georgia United States
    6 Northwestern University Chicago Illinois United States
    7 Beth Israel Deaconess Medical Center Boston Massachusetts United States
    8 Brigham and Women's Hospital Boston Massachusetts United States
    9 Massachusetts General Hospital Boston Massachusetts United States
    10 Bay State Medical Center Springfield Massachusetts United States
    11 Henry Ford Health System Detroit Michigan United States
    12 Wayne State - Detroit Receiving Hospital Detroit Michigan United States
    13 Cooper Health Camden New Jersey United States
    14 North Shore University Hospital Manhasset New York United States
    15 Staten Island University Hospital Staten Island New York United States
    16 SUNY Stony Brook Stony Brook New York United States
    17 Duke University Medical Center Durham North Carolina United States
    18 Wake Forest University Winston-Salem North Carolina United States
    19 Cleveland Clinic Cleveland Ohio United States
    20 Albert Einstein Medical Center Philadelphia Pennsylvania United States
    21 Temple University Philadelphia Pennsylvania United States
    22 University of Pennsylvania Philadelphia Pennsylvania United States
    23 Brown University Providence Rhode Island United States
    24 Virginia Commonwealth University Medical Center Richmond Virginia United States

    Sponsors and Collaborators

    • Biosite

    Investigators

    • Principal Investigator: Emanuel Rivers, MD, MPH, Henry Ford Hospital
    • Principal Investigator: Mitchell Levy, MD, Rhode Island Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00472628
    Other Study ID Numbers:
    • BSTE-0501 - CLOSED
    • Study Closed 9/13/07
    First Posted:
    May 14, 2007
    Last Update Posted:
    Jul 21, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Emergencies

    Study Results

    No Results Posted as of Jul 21, 2015