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

June 12, 2008
June 12, 2008
March 2008
March 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
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Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients
Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II

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

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum of patients who are undergoing liver transplantation surgery

Non-Probability Sample

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

Liver Transplant
Not Provided
  • 1
    Live Donor
  • 2
    Cadaveric Donor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
April 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00698399
80237
No
Jeffrey Michael Waldman, M.D., Vanderbilt University Medical Center
Vanderbilt University
University of California, San Francisco
Principal Investigator: Jeffrey M Waldman, M.D. Vanderbilt University
Vanderbilt University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP