A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair. - Full Text View

Purpose

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.

Condition

Aortic Aneurysm, Thoracic
Systemic Inflammatory Response Syndrome

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Prospective

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

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood and saliva samples will be obtained for the purposes of this study and will be maintained until complete analysis of the samples for all patients is complete.

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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.

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 entering the hospital for elective TAAA repair

Criteria

Inclusion Criteria:

Elective TAAA repair

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739557

Contacts


Contact: Kenneth S Helmer, MD	713-500-6362	Kenneth.S.Helmer@uth.tmc.edu

Locations


United States, Texas
	Memorial Hermann Hospital	Recruiting
	Houston, Texas, United States, 77030
	Contact: Kenneth Helmer, MD 713-500-6362 Kenneth.S.Helmer@uth.tmc.edu
	Principal Investigator: Kenneth S Helmer

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators


Principal Investigator:	Kenneth S Helmer, MD	Univ. of Texas Health Science Center at Houston

More Information

Responsible Party:	Univ. of Texas Health Science Center at Houston ( Kenneth Helmer, M.D. )
Study ID Numbers:	07-0257
First Received:	August 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739557
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

elective TAAA repair

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Aortic Diseases

Shock

Aortic Aneurysm, Thoracic

Aneurysm

Vascular Diseases

Aortic Aneurysm

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00739557