Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis (Histone)

This study has been completed.
Sponsor:
Collaborator:
Oklahoma Medical Research Foundation
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01012115
First received: November 9, 2009
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

In an effort to better understand the interaction between the different mediators, the investigators propose to examine the time course of mediators, the indexes of organ injury and the coagulation cascade.


Condition
Sepsis

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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 500
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

All patients admitted to the ICU (Including VA Medical Center, University Hospital and Presbyterian hospital) will be screened for enrollment in the study. Patients who have the diagnosis of sepsis will be asked to volunteer. We will match sepsis patients with other ICU patients without the diagnosis of sepsis. The latter will also be asked to volunteer.

Patients will be stratified into three groups:

  • Sepsis
  • SIRS of non-septic origin
  • Other ICU patients

Routine laboratory data and clinical data (see flow sheet) will be collected. The plasma or serum will be frozen separately until the target number of patients is met. Measurements of inflammatory mediators and other cytokines/injury markers will be carried out at that point.

  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

Patients admitted to the ICU with suspected or proven sepsis.

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: NCT01012115

Locations
United States, Oklahoma
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Oklahoma Medical Research Foundation
Investigators
Principal Investigator: Gary T Kinasewitz, MD OU Health Sciences Center
  More Information

No publications provided

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01012115     History of Changes
Other Study ID Numbers: 14849
Study First Received: November 9, 2009
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Histones
organ failure
sepsis

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

ClinicalTrials.gov processed this record on July 22, 2014