Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis

Sepsis Clinical Trial

— Histone  

Official title:

Temporal Behavior of Coagulation Factors,Cytokines and Tissue Injury Markers in Sepsis: Validation of Extracellular Histones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012115
• Other study ID #: 14849
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: April 5, 2012
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to the ICU

Exclusion Criteria:

• No blood draws scheduled

• Hemoglobin level < 6.5 gm/dl

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	OU Medical Center	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Oklahoma Medical Research Foundation

Country where clinical trial is conducted

United States,