HepQuant to Predict Hepatic Encephalopathy After TIPS

Northwestern University

Status

Withdrawn

Conditions

Hepatic Encephalopathy

Cirrhosis, Liver

Treatments

Diagnostic Test: HepQuant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04664621

STU00210205

Details and patient eligibility

About

A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects over the age of 18 able to provide consent
Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites

Exclusion criteria

Prisoners
Pregnant women
Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
Subjects taking beta-blocker medications or angiotensin converting enzyme inhibitors
Subjects with evidence of porto-systemic shunts present on imaging (eg splenorenal shunt)
Subjects with calculated MELD score >12 based on most recent laboratory values before consent
Subjects with prior history of overt hepatic encephalopathy (grade 3-4) that was primary reason for hospitalization. Episodes of hepatic encephalopathy that were the consequence of other precipitating event (such as variceal bleeding or infection) will not be considered exclusionary.
Subjects with a known sensitivity to albumin preparations, any ingredient in the formulation, or components of the container
Subjects unable to fast for >5 hours prior to the HepQuant administration or subjects who are unable to drink the oral dose of the cholate (~40mL of liquid).