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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-01-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractory Ascites Hepatic Hydrothorax Hepatic Encephalopathy Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Oral glutamine challenge

Intervention Type OTHER

Blood ammonia determination before, 30-, 60-, and 90-minute, after intake of 10 g of L-glutamine

Psychometric Tests

Intervention Type OTHER

PHES (portosystemic hepatic encephalopathy score) and ICT (inhibitory control test)

Interventions

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Oral glutamine challenge

Blood ammonia determination before, 30-, 60-, and 90-minute, after intake of 10 g of L-glutamine

Intervention Type OTHER

Psychometric Tests

PHES (portosystemic hepatic encephalopathy score) and ICT (inhibitory control test)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No