NCT00472628

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

24 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

First QC Date

May 10, 2007

Last Update Submit

July 20, 2015

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

LA County/ USC

Los Angeles, California, United States

Location

Olive View Medical Center - UCLA

Sylmar, California, United States

Location

Denver Health

Denver, Colorado, United States

Location

George Washington University

Washington D.C., District of Columbia, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Bay State Medical Center

Springfield, Massachusetts, United States

Location

Henry Ford Health System

Detroit, Michigan, United States

Location

Wayne State - Detroit Receiving Hospital

Detroit, Michigan, United States

Location

Cooper Health

Camden, New Jersey, United States

Location

North Shore University Hospital

Manhasset, New York, United States

Location

Staten Island University Hospital

Staten Island, New York, United States

Location

SUNY Stony Brook

Stony Brook, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Wake Forest University

Winston-Salem, North Carolina, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Location

Temple University

Philadelphia, Pennsylvania, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Brown University

Providence, Rhode Island, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emanuel Rivers, MD, MPH

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR
  • Mitchell Levy, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

May 1, 2007

Study Completion

August 1, 2007

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations