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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Arkansas

Current Primary Outcome: Overt hepatic encephalopathy [ Time Frame: up to 18 months ]

Classified according to West Haven criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Arkansas

Dates:
Date Received: December 26, 2013
Date Started: May 2013
Date Completion:
Last Updated: April 14, 2017
Last Verified: April 2017