NCT04073290RecruitingPhase 4
Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Prevention of Hepatic Encephalopathy by Administration of Rifaximin and Lactulose in Patients With Liver Cirrhosis Undergoing TIPS Placement: a Multi-centre Randomized, Double Blind, Placebo Controlled Trial.
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 238 (estimated)
- First submitted
- 27 Aug 2019
- Start date
- 21 Jan 2020
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- High blood pressure
- NCT number
- NCT04073290
- EudraCT number
- 2018-004323-37
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 238
- From 21 Jan 2020 to the primary completion date, 30 Sept 2026
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
- Non-cirrhotic portal hypertension
- Portal vein thrombosis (main trunk)
- HIV
- Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease
Age
- Age \> 80 years
Other
- Any absolute contraindications for TIPS placement
- Use of ciclosporin
- Current or recent (\<3 months) use of rifaximin
- Pregnant or breastfeeding women
- Patients refusing or unable to sign informed consent
Who the study is looking for
- Elective TIPS placement for refractory ascites or recurrent variceal bleeding:
- Recurrent tense ascites and one or more of the following criteria:
- Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide).
- Kidney insufficiency (Creatinine \> 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium \< 125 mmol/L, Potassium \> 5.5 mmol/L) induced by diuretics.
- 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:
- 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
- Age ≥18 years
- Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
- Signed informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaire Ziekenhuizen Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Academic Medical Centre Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Radboud University Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.