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Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients

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ClinicalTrials.gov Identifier: NCT00698399
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Brief Summary:
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 or disease
Liver Transplant

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

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II
Study Start Date : March 2008
Actual Primary Completion Date : February 2, 2010
Actual Study Completion Date : February 2, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Live Donor
2
Cadaveric Donor



Biospecimen Retention:   Samples Without DNA
serum of patients who are undergoing liver transplantation surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698399


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
University of California, San Francisco
Investigators
Principal Investigator: Jeffrey M Waldman, M.D. Vanderbilt University Medical Center

Additional Information:
Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00698399     History of Changes
Other Study ID Numbers: 80237
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Vanderbilt University Medical Center:
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