A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.

Withdrawn

• Conditions: Aortic Aneurysm, Thoracic; Systemic Inflammatory Response Syndrome

• Registration Number: NCT00739557
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications.

Detailed Description

Patients will be invited to participate in this study prior to the TAAA repair procedure. Prior to the surgery, baseline blood and saliva samples will be collected. Following the surgery, blood and saliva samples will be collected for 48 hours. In addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. The patient data will be reviewed for the first 30 days for morbidity and mortality assessment.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Elective TAAA repair

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10.	30 days

Secondary Outcome Measures

Name	Time	Method
To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity	30 days