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.

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Key information

Conditions

Alcohol-related Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Memorial Hospital, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 12 month follow up

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%

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Mar 18, 2013
Registry last updated: Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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