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

November 9, 2009
April 5, 2012
October 2009
September 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01012115 on ClinicalTrials.gov Archive Site
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Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis
Temporal Behavior of Coagulation Factors,Cytokines and Tissue Injury Markers in Sepsis: Validation of Extracellular Histones

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Non-Probability Sample

Patients admitted to the ICU with suspected or proven sepsis.

Sepsis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Admission to the ICU

Exclusion Criteria:

  • No blood draws scheduled
  • Hemoglobin level < 6.5 gm/dl
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012115
14849
No
Gary Kinasewitz, University of Oklahoma
University of Oklahoma
Oklahoma Medical Research Foundation
Principal Investigator: Gary T Kinasewitz, MD OU Health Sciences Center
University of Oklahoma
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP