Alcohol Biomarkers in Post-Liver Transplant Patients

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.

Study Overview

• Status: Completed
• Conditions: Alcohol-related Liver Disease

Detailed Description

Patients who have a positive PEth will be asked to have a confirmatory test performed 10-14 days after a positive result (PEth >20ng/ml). The rationale for this procedure is to determine the test retest reliability of this marker and as well as being able to correlate levels of drinking with changes in biomarker levels over time. There is limited information on the length of time PEth levels remain elevated in transplant patients after drinking episodes.

Hypothesis H.1. PEth will have a significantly higher "area under the Receiver Operating Characteristic (ROC) curve" in a sample of post-transplant patients who report any alcohol use in the past 30 days compared to the control group.

H.2. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report daily alcohol use of >40 grams/day (three drinks/day) in the past 30 days compared to the control group.

H.3. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report heavy episodic drinking (>60 grams of alcohol, eight or more occasions in the past 30 days) compared to the control group.

H.4. PEth levels will be <20 ng/ml in the control sample of 50 post transplant patients who do not have a history of alcohol dependence or alcohol related liver disease.

H.5. The test-retest reliability of PEth will be >0.90.

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin, Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Transplant center patients

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individuals who do not consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Michael F Fleming, MD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: STU31235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO