Indicators of Inflammation and Coagulation in Sepsis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01128283
First received: May 20, 2010
Last updated: September 11, 2014
Last verified: September 2014
  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 University of Oklahoma:

Primary Outcome Measures:
  • Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01128283     History of Changes
Other Study ID Numbers: 09681
Study First Received: May 20, 2010
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014