Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00698399
First received: June 12, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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

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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Biospecimen Retention:   Samples Without DNA

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Jeffrey Michael Waldman, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00698399     History of Changes
Other Study ID Numbers: 80237
Study First Received: June 12, 2008
Last Updated: June 12, 2008
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

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on October 16, 2014