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

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ClinicalTrials.gov Identifier: NCT00472628
Recruitment Status : Withdrawn (Change in company strategy)
First Posted : May 14, 2007
Last Update Posted : July 21, 2015
Sponsor:
Information provided by:
Biosite

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
Sepsis 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
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 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472628


  Show 24 Study Locations
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: Emanuel Rivers, MD, MPH Henry Ford Hospital
Principal Investigator: Mitchell Levy, MD Rhode Island Hospital

ClinicalTrials.gov Identifier: NCT00472628     History of Changes
Other Study ID Numbers: BSTE-0501 - CLOSED
Study Closed 9/13/07
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Emergencies
Sepsis
Toxemia
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation