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Indicators of Inflammation and Coagulation in Sepsis

Sponsor
University of Oklahoma (Other)
Overall Status
Completed
CT.gov ID
NCT01128283
Collaborator
(none)
500
Enrollment
1
Location
147.9
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We will collect blood samples from patients with the diagnosis of sepsis and other ICU patients. We will describe the course of different mediator levels and organ injury markers and follow their progression throughout the course of the study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After informed consent is obtained 5 cc of blood is collected on the day of admission and on days 0, 1, 3, and 7 thereafter. Plasma is collected and frozen for the subsequent measurement of biomarkers.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis
    Study Start Date :
    Jan 1, 2002
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Sepsis

    Patients with severe sepsis
    Non-infected

    ICU patients without evidence of infection

    Outcome Measures

    Primary Outcome Measures

    1. Death [30 days]

      Survival at 30 days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Admission to the ICU
    Exclusion Criteria:

    • No blood draws scheduled

    • Hemoglobin level < 6,5 gm/dl

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OU Medical Center Oklahoma City Oklahoma United States 73104

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    • Principal Investigator: Gary T. Kinasewitz, MD, University of Oklahoma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Kinasewitz, Principal Investigator, University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT01128283
    Other Study ID Numbers:
    • 09681
    First Posted:
    May 21, 2010
    Last Update Posted:
    Sep 12, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Gary Kinasewitz, Principal Investigator, University of Oklahoma
    Sepsis
    organ failure
    cytokines
    clotting factors
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Sep 12, 2014