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

University of Arkansas

Status: Terminated

Conditions: Hepatic Hydrothorax; Hepatic Encephalopathy; Refractory Ascites; Cirrhosis

Treatments: Other: Oral glutamine challenge; Other: Psychometric Tests

Study type: Observational

Funder types: Other

Identifiers

NCT02026609

#135318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 1 patient group

TIPS

Description:

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.

Treatment:

Other: Psychometric Tests

Other: Oral glutamine challenge