Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 27, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how to prevent a condition called hepatic encephalopathy (HE) in patients who undergo a procedure known as TIPS (Transjugular Intrahepatic Portosystemic Shunt). HE is a serious complication that can happen after TIPS, affecting how the brain functions due to liver problems. The researchers are testing two medications, rifaximin and lactulose, to see if they can help reduce the risk of developing HE after the procedure.

To join the trial, participants must be adults aged 18 and older who are scheduled for a TIPS procedure due to severe liver issues, like fluid buildup or repeated bleeding from enlarged veins in the esophagus. They should have confirmed liver cirrhosis, which is a severe scarring of the liver. Participants will need to provide informed consent and will be monitored throughout the study for any changes in their condition. It's important to note that there are specific criteria that would exclude some individuals from participating, such as being over 80 years old or having certain other health conditions. Overall, this trial aims to find a way to help patients with liver cirrhosis avoid complications after TIPS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Elective TIPS placement for refractory ascites or recurrent variceal bleeding:
• Recurrent tense ascites and one or more of the following criteria:
• • i. Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide).
• • ii. Kidney insufficiency (Creatinine \> 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium \< 125 mmol/L, Potassium \> 5.5 mmol/L) induced by diuretics.
• • iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps).
• Recurrent variceal bleeding, not responsive to treatment with endoscopic band ligation and beta-blockers, with a high risk of failure of endoscopic treatment:
• • i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy
• • 2. Age ≥18 years
• • 3. Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
• • 4. Signed informed consent
• Exclusion Criteria:
• • 1. Any absolute contraindications for TIPS placement
• • 2. Use of ciclosporin
• • 3. Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
• • 4. Age \> 80 years
• • 5. Non-cirrhotic portal hypertension
• • 6. Portal vein thrombosis (main trunk)
• • 7. HIV
• • 8. Current or recent (\<3 months) use of rifaximin
• • 9. Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease
• • 10. Pregnant or breastfeeding women
• • 11. Patients refusing or unable to sign informed consent