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Indicators of Inflammation and Coagulation in Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128283
First Posted: May 21, 2010
Last Update Posted: September 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
  Purpose
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
Sepsis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis

Resource links provided by NLM:


Further study details as provided by Gary Kinasewitz, University of Oklahoma:

Primary Outcome Measures:
  • Death [ Time Frame: 30 days ]
    Survival at 30 days


Biospecimen Retention:   Samples Without DNA
Plasma

Enrollment: 500
Study Start Date: January 2002
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sepsis
Patients with severe sepsis
Non-infected
ICU patients without evidence of infection

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.
  Eligibility

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
Sampling Method:   Non-Probability Sample
Study Population
ICU patients
Criteria

Inclusion Criteria:

  • Admission to the ICU

Exclusion Criteria:

  • No blood draws scheduled
  • Hemoglobin level < 6,5 gm/dl
  Contacts and Locations
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): NCT01128283


Locations
United States, Oklahoma
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
  More Information

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01128283     History of Changes
Other Study ID Numbers: 09681
First Submitted: May 20, 2010
First Posted: May 21, 2010
Last Update Posted: September 12, 2014
Last Verified: September 2014

Keywords provided by Gary Kinasewitz, University of Oklahoma:
Sepsis
organ failure
cytokines
clotting factors

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