Alcohol Biomarkers in Post-Liver Transplant Patients
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | March 2013 |
| End Date: | October 2015 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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