Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis

NCT ID: NCT01012115

Last Updated: 2012-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-09-30

Brief 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.

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Admission to the ICU

Exclusion Criteria

• No blood draws scheduled
• Hemoglobin level < 6.5 gm/dl

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oklahoma Medical Research Foundation

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Gary Kinasewitz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary T Kinasewitz, MD

Role: PRINCIPAL_INVESTIGATOR

OU Health Sciences Center

Locations

OU Medical Center

Oklahoma City, Oklahoma, United States

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

14849

Identifier Type: -

Identifier Source: org_study_id