Expired Study
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Nashville, Tennessee 37212


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.


Study summary:

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


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


Study is Available At:


Original ID:

80237


NCT ID:

NCT00698399


Secondary ID:


Study Acronym:


Brief Title:

Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients


Official Title:

Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey M Waldman, M.D.
Principal Investigator
Vanderbilt University Medical Center

Study Dates

Start Date:March 2008
Completion Date:February 2, 2010
Completion Type:Actual
Primary Completion Date:February 2, 2010
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 27, 2018
First Received Date:June 12, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Live Donor
Study Arm Type:Other
Arm Name:2
Description:Cadaveric Donor

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of California, San Francisco

Samples and Retentions

Sample Retention:Samples Without DNA
Description: serum of patients who are undergoing liver transplantation surgery
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
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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