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

Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • LA County/ USC
    • Sylmar, California, United States
      • Olive View Medical Center - UCLA
  • Colorado
    • Denver, Colorado, United States
      • Denver Health
  • District of Columbia
    • Washington, District of Columbia, United States
      • George Washington University
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University
  • Illinois
    • Chicago, Illinois, United States
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States
      • Brigham and Women's Hospital
    • Springfield, Massachusetts, United States
      • Bay State Medical Center
  • Michigan
    • Detroit, Michigan, United States
      • Henry Ford Health System
    • Detroit, Michigan, United States
      • Wayne State - Detroit Receiving Hospital
  • New Jersey
    • Camden, New Jersey, United States
      • Cooper Health
  • New York
    • Manhasset, New York, United States
      • North Shore University Hospital
    • Staten Island, New York, United States
      • Staten Island University Hospital
    • Stony Brook, New York, United States
      • SUNY Stony Brook
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States
      • Wake Forest University
  • Ohio
    • Cleveland, Ohio, United States
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States
      • Temple University
  • Rhode Island
    • Providence, Rhode Island, United States
      • Brown University
  • Virginia
    • Richmond, Virginia, United States
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Biosite
• Investigators: Principal Investigator: Emanuel Rivers, MD, MPH, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: May 10, 2007
• First Submitted That Met QC Criteria: May 11, 2007
• First Posted (Estimate): May 14, 2007

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: BSTE-0501 - CLOSED; Study Closed 9/13/07