Alcohol Biomarkers in Post-Liver Transplant Patients

NCT01812226 | Completed

• 1 other identifier: STU31235
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare the predictive validity and reliability of PEth testing at detecting alcohol use in post liver transplant patients. A prospective cohort study will be used to test the primary hypothesis. Subjects enrolled in the study will be followed for 12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and depression. The six and 12 months interview will focus on previous 30 day alcohol use. The baseline, six and 12 months interviews will be conducted face-to-face at each site. While many patients who receive a transplant do not live near the academic medical center that performed the surgery patient, they normally have a transplant clinic visit 1-2 times per year. Medical records and transplant databases will be assessed to assess the other variables of interest.

Conditions

Alcohol-related Liver Disease

Outcome Measures

Primary Outcomes (1)

• specificity of PEth to detect alcohol use among post-transplant patients

  The criteria standard on which we will base the specificity will be a combination of patient self-report, family member report and clinician/medical record data. Subjects in whom any concern of current alcohol use, from any of these sources, would be considered a positive for current drinking. The PEth levels would then be compared to this standard of current alcohol use Data from previous research suggests PEth has a specificity close to 100%

  12 month follow up

Study Arms (2)

experimental group

This group will consist of men and women who received a liver transplant for alcohol-related liver disease.

control group

This group will consist of men and women who had a liver transplant for reasons that are not alcohol-related.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transplant center patients

You may qualify if:

• men and women 18 years and over
• Participant must have received a liver transplant after January 1, 2003
• Participant must be six months or more post-transplant
• Mini-mental status score of greater than or equal to 20
• Participant must be well enough to participate in the research procedures over a 12 month period
• Participant must continue to be followed by the transplant center

You may not qualify if:

• Individuals who do not consent

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected to detect PEth levels.

Study Officials

• Michael F Fleming, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 18, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)