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

Sepsis Clinical Trial

— MINDSET  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00472628
• Other study ID #: BSTE-0501 - CLOSED
• Secondary ID: Study Closed 9/1
• Status: Withdrawn
• Phase: N/A
• First received: May 10, 2007
• Last updated: July 20, 2015
• Start date: May 2007
• Est. completion date: August 2007

Study information

• Verified date: July 2015
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis

Intervention

Procedure:
• Blood samples collected

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
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	Cooper Health	Camden	New Jersey
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Denver Health	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Wayne State - Detroit Receiving Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	LA County/ USC	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
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	Bay State Medical Center	Springfield	Massachusetts
United States	Staten Island University Hospital	Staten Island	New York
United States	SUNY Stony Brook	Stony Brook	New York
United States	Olive View Medical Center - UCLA	Sylmar	California
United States	George Washington University	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States,