Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients - Full Text View

Sponsors and Collaborators:	Vanderbilt University University of California, San Francisco
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00698399

Purpose

This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.

Condition
Liver Transplant

MedlinePlus related topics: Liver Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II

Further study details as provided by Vanderbilt University:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum of patients who are undergoing liver transplantation surgery

Enrollment:	40
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Live Donor
2 Cadaveric Donor

Detailed Description:

The Departments of Anesthesiology are conducting an observational trial of markers in the serum of patients who are undergoing liver transplantation surgery. This study will utilize the biological markers, trimethylamine-N-oxide (TMAO), NGAL, and cystatin-C, sensitive markers of renal medullary injury in the blood and allantoin, a marker of oxidative stress as indicators of renal injury in a kidney during liver transplants. It is hypothesized that: (1) these markers are less pronounced in living donor liver transplant recipient patients than in cadaveric liver transplant recipients, and (2) these markers are less pronounced in cadaveric liver transplant recipients in which a "piggy-back" technique was used versus recipients in which a total venous occlusion technique was used. This study will be done in a multi-center format, along with researchers at UCSF

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

Subjects will be recruited from those on the list awaiting liver transplantation at Vanderbilt University Medical Center (VUMC). They will be recruited by the investigators prior to the time of their transplantation surgery

Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) Class I-V.
Patient is undergoing elective Liver Transplant Surgery.
Patient is an adult, 18 years old or older.

Exclusion Criteria:

Patients < 18 Years of Age
Patients who are pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698399

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University

University of California, San Francisco

Investigators

Principal Investigator:

Jeffrey M Waldman, M.D.

Vanderbilt University

More Information

Additional Information:

Vanderbilt University Medical Center Department of Anesthesiology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vanderbilt University Medical Center ( Jeffrey Michael Waldman, M.D. )
Study ID Numbers:	80237
Study First Received:	June 12, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00698399 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

liver
transplant
TMAO
NGAL
cystatin-C

Ischemia Reperfusion Injury
Liver Transplant
LTx
allantion

Study placed in the following topic categories:

Postoperative Complications
Vascular Diseases
Ischemia
Cystatins
Reperfusion Injury

Additional relevant MeSH terms:

Pathologic Processes
Postoperative Complications
Vascular Diseases

Cardiovascular Diseases
Ischemia
Reperfusion Injury

ClinicalTrials.gov processed this record on May 07, 2009