Glutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)

April 14, 2017 updated by: University of Arkansas
Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients with cirrhosis and refractory ascites. However, mental changes known as hepatic encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also predispose patients to HE. The aim of the present study is to assess if both the OGC and psychometric tests can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of HE. The role of muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In cirrhosis, up to 10% of patients develop refractory ascites. TIPS (transjugular intrahepatic portosystemic shunt) is the first-line therapy for these patients. However, 30% will go on to develop hepatic encephalopathy (HE) as a consequence of TIPS, and there is no effective method to predict this outcome. Oral glutamine challenge (OGC) is used to functionally assess ammonia metabolism, and the severity of porto-systemic collateralization, and it has been used to predict overt HE. Psychometric tests (i.e. Psychometric Hepatic Encephalopathy Score [PHES] and inhibitory control test) allow the identification of covert forms of HE and can also predict overt HE. Severe sarcopenia may also predispose patients to HE. The aim of the present study is to assess if both the degree of impairment in ammonia metabolism as estimated with the OGC, and cognitive status as determined by psychometric tests, can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of overt HE. The role of sarcopenia in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 1P1
        • University of Montreal
  • Switzerland
      • Geneva, Switzerland
        • University Hospitals of Geneva
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients will be recruited from the Gastroenterology / Hepatology Clinics at UAMS and other participating centers. Those fulfilling inclusion/exclusion criteria will be invited to participate.

Description

Inclusion Criteria:

  • Cirrhosis (any etiology)
  • Refractory ascites or hepatic hydrothorax and plan for TIPS placement

Exclusion Criteria:

  • Well-documented overt hepatic encephalopathy, either persistent or at the time of screening

  • Any contraindication for TIPS placement

    • Except for coagulopathy and thrombocytopenia (decided on an individual basis)
  • Uncontrolled depression/anxiety disorder or use of antipsychotic drugs
  • Active use of alcohol or illicit drugs
  • History of dementia
  • TIPS planned for another indication.
  • Active alcoholic liver disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TIPS
Patients 18-75 year old with refractory ascites or hepatic hydrothorax and cirrhosis, eligible for TIPS placement. All patients will have a baseline oral glutamine challenge and psychometric tests.
Other: Oral glutamine challenge
Blood ammonia determination before, 30-, 60-, and 90-minute, after intake of 10 g of L-glutamine
Other: Psychometric Tests
PHES (portosystemic hepatic encephalopathy score) and ICT (inhibitory control test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overt hepatic encephalopathy
Time Frame: up to 18 months
Classified according to West Haven criteria.
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia
Time Frame: Baseline and 6 months post-TIPS
According to CT scan L3 area of muscle mass
Baseline and 6 months post-TIPS
Physical activity
Time Frame: Baseline and 6 months post-TIPS
Pedometer readings and physical activity questionnaire
Baseline and 6 months post-TIPS
Dietary Intake
Time Frame: Baseline and 6 months post-TIPS
Food frequency questionnaire (FFQ, NutritionQuest, Berkeley, CA)
Baseline and 6 months post-TIPS

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle trophic factors
Time Frame: Baseline and 6 months post-TIPS
IGF-1 and myostatin levels
Baseline and 6 months post-TIPS
Glutaminase gene variations
Time Frame: Baseline
Genetic variations in the glutaminase gene (located at 2q-32-134) consisting of single nucleotide polymorphisms (SNPs) identifying a microsatellite of GCA repeats in the 5' untranslated region
Baseline
Psychometric tests
Time Frame: 3 and 6 months post-TIPS
Repeat PHES and ICT
3 and 6 months post-TIPS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

University Hospital, Geneva
Université de Montréal

Investigators

  • Principal Investigator: Andres Duarte-Rojo, MD, MSc, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 27, 2015

Study Completion (Actual)

January 27, 2015

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #135318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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