Clinical trial NCT00472628: Multi-marker INDex for the Risk Assessment of Sepsis in the Emergency departmenT (MINDSET)
Official title: Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sepsis
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2007-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA County/ USC
state: California
city: Sylmar
country: United States
facility: Olive View Medical Center - UCLA
state: California
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Bay State Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State - Detroit Receiving Hospital
state: Michigan
city: Camden
country: United States
facility: Cooper Health
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Henry Ford Hospital
name: Emanuel Rivers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Mitchell Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: