Glutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Stopped early
Conditions studied: Refractory Ascites, Hepatic Hydrothorax, Hepatic Encephalopathy, Cirrhosis
In brief
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.
Key facts
- Study ID
- NCT02026609
- Run by
- University of Arkansas
- People needed
- 3
- Starts
- 2013-05-01
- Expected to finish
- 2015-01-27
- Last updated by the study team
- 2017-04-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cirrhosis (any etiology)
- Refractory ascites or hepatic hydrothorax and plan for TIPS placement
You may not qualify if…
- 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.
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- University of Montreal — Montreal, Quebec, Canada
- University Hospitals of Geneva — Geneva, Switzerland
Full record on ClinicalTrials.gov
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