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Study on Preventing Hepatic Encephalopathy with Rifaximin and Lactulose in Patients with Alcoholic Liver Cirrhosis Undergoing TIPS Placement

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of a condition called hepatic encephalopathy in patients with liver cirrhosis. Liver cirrhosis is a disease where the liver becomes severely scarred, often due to long-term damage such as from alcohol use. Hepatic encephalopathy is a complication that can occur in people with liver cirrhosis, leading to confusion and other mental changes. The trial involves patients who are undergoing a procedure known as a transjugular intrahepatic portosystemic shunt (TIPS), which is used to treat complications of liver cirrhosis.

The study will test the effectiveness of two medications, Rifaximin and Lactulose, in preventing hepatic encephalopathy after the TIPS procedure. Rifaximin is an antibiotic that works in the gut, and Lactulose is a type of sugar that helps reduce the amount of toxins in the blood. Some participants will receive these medications, while others will receive a placebo, which looks like the medication but does not contain any active ingredients. The purpose of the study is to see if taking Rifaximin and Lactulose can lower the chances of developing hepatic encephalopathy within the first three months after the TIPS procedure.

Participants in the study will be randomly assigned to receive either the medications or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medications and who is receiving the placebo. This helps ensure that the results are not biased. The trial will last for a period of up to 13 weeks, during which time participants will be monitored for any signs of hepatic encephalopathy and other health changes. The findings from this study could help improve the care and outcomes for patients with liver cirrhosis undergoing the TIPS procedure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed through signed informed consent. Eligibility is based on criteria such as age (18 years or older) and a confirmed diagnosis of liver cirrhosis.
Step 2
Treatment initiation
The study involves the administration of medications to prevent hepatic encephalopathy, a condition affecting brain function due to liver disease.
Participants receive either rifaximin (550 mg film-coated tablets) or a placebo, taken orally. The exact dosage and frequency are determined by the study protocol.
Additionally, lactulose (670 mg/ml syrup) is administered orally. The dosage and frequency are specified in the study protocol.
Step 3
Treatment duration
The treatment is administered for a period of three months following the placement of a transjugular intrahepatic portosystemic shunt (TIPS), a procedure used to treat complications of liver cirrhosis.
Step 4
Monitoring and assessment
Participants are monitored for the development of overt hepatic encephalopathy (OHE) within the first three months after TIPS placement. This is assessed using the West Haven criteria, a system used to evaluate the severity of hepatic encephalopathy.
Secondary assessments include monitoring for a second episode of OHE, development of OHE or minimal hepatic encephalopathy (MHE) between three and twelve months post-TIPS, and other cognitive function tests.
Step 5
Study completion
The study is estimated to conclude by December 31, 2024. Participants' health and cognitive function are evaluated throughout the study duration to assess the effectiveness of the treatment.

Who can join the trial?

7 criteria

The patient must have a confirmed diagnosis of **Alcoholic liver cirrhosis**. This means the liver is damaged due to long-term alcohol use.
The patient must be scheduled for an **Elective TIPS placement**. TIPS stands for Transjugular Intrahepatic Portosystemic Shunt, a procedure to help blood flow in the liver.
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The TIPS placement is needed for **refractory ascites** or **recurrent variceal bleeding**.
- **Refractory ascites**: This is a condition where fluid builds up in the belly and does not respond to the highest dose of water pills (diuretics).
- **Recurrent variceal bleeding**: This is bleeding from swollen veins in the food pipe that does not stop with usual treatments.
- The patient must be 18 years of age or older.
- The patient must have confirmed **liver cirrhosis**. This can be shown by a liver biopsy, a special scan called elastography, or a combination of usual tests and scans.
- The patient must sign an **informed consent** form. This means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who do not have a confirmed diagnosis of alcoholic liver cirrhosis cannot participate. This means that if a doctor has not officially determined that you have this specific liver condition, you are not eligible.
Patients who are not undergoing a procedure called Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement cannot participate. TIPS is a procedure that creates a new pathway for blood flow in the liver.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements that must be met.
Patients who belong to a vulnerable population are not eligible. This means people who might need special protection or care, like those with certain disabilities or conditions, cannot join the study.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
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Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

Rifaximin
is an antibiotic that works in the gut to reduce the number of bacteria that produce toxins. These toxins can affect the brain, especially in people with liver problems. In this trial, rifaximin is used to help prevent hepatic encephalopathy, a condition that can occur after a procedure called TIPS, which is used to treat complications of liver cirrhosis.
Lactulose
is a type of sugar that is not absorbed by the body. It works by drawing water into the bowel, which helps to soften stools and promote bowel movements. This process helps to reduce the amount of toxins in the blood that can affect the brain. In this trial, lactulose is used alongside rifaximin to help prevent hepatic encephalopathy in patients undergoing the TIPS procedure.

What is already known about the treatment

Rifaximin
Rifaximin is an antibiotic administered orally, typically in tablet form. It is currently well-established in medical literature and is used primarily for the treatment of hepatic encephalopathy, a condition associated with liver disease. The medication works by reducing the amount of ammonia-producing bacteria in the gut, which helps decrease the risk of brain function decline in patients with liver cirrhosis. Rifaximin is classified as a rifamycin antibacterial agent.
Lactulose
Lactulose is a synthetic sugar used as a laxative, administered orally in liquid form. It is widely recognized in medical practice for its role in managing hepatic encephalopathy in patients with liver disease. Lactulose works by drawing water into the bowel, which helps to soften stools and reduce the absorption of ammonia in the intestines, thereby lowering blood ammonia levels. It is classified as an osmotic laxative.

Investigated diseases

Alcoholic Liver Cirrhosis – This disease is a severe liver condition caused by long-term excessive alcohol consumption. It involves the replacement of healthy liver tissue with scar tissue, which impairs the liver's ability to function properly. As the disease progresses, the liver becomes increasingly damaged, leading to complications such as fluid buildup in the abdomen, bleeding from veins in the esophagus, and confusion due to toxin buildup in the brain. The liver's ability to process nutrients, hormones, and drugs is also compromised. Over time, the liver's regenerative capacity is overwhelmed, resulting in significant health issues.