conventional therapy: Conventional treatment of decompensated cirrhosis mainly includes anti-hepatic fibrosis drugs, albumin infusion, diuretics, peritoneal drainage, esophageal variceal ligation, endoscopic tissue adhesive injection, blood purification, and liver transplantation.
propranolol: Propranolol will be started with 10-20 mg/day for the propranolol group, which will be gradually increased to the maximum tolerance dosage or achieve a heart rate of 55-60 beats per minute and a systolic blood pressure of 90mmHg.
Study summary
Non selective beta blockers (NSBBs), such as propranolol and nadolol, are mainstay therapies for portal hypertension in cirrhosis, but their efficacy and safety vary depending on the stage of the disease. Emerging evidence suggests that NSBBs may worsen the prognosis of advanced cirrhosis, especially in patients with a model for end-stage liver disease (MELD) score of \>9. The purpose of this randomized controlled trial is to evaluate the effects of the use of propranolol as recommended by the guideline on the prognosis in cirrhotic patients with a MELD score of \>9.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* patients' age ≥18 years;
* patients with a definitive diagnosis of liver cirrhosis;
* patients with a MELD score of \>9;
* patients with a history of decompensation or those who are experiencing their first decompensation, such as ascites, variceal bleeding, or hepatic encephalopathy (HE);
* patients' informed consents.
Exclusion Criteria:
* patients without a definite indication for NSBBs;
* patients with an absolute contraindication of NSBBs (severe bronchospasm, asthma, severe psychosis, high-degree atrioventricular block, etc.);
* patients with hypersensitivity to NSBBs;
* patients who had been treated with NSBBs before 2 weeks of enrollment;
* patients with occlusive portal vein thrombosis;
* patients who had undergone liver transplantation;
* patients who had undergone transjugular intrahepatic portosystemic shunt (TIPS);
* patients with a definitive diagnosis of hepatocellular carcinoma;
* patients with an estimated life time of \<12 months due to the presence of any comorbidities;
* patients who are currently pregnant or breast-feeding.
Primary outcome measure(s)
The time from randomization to the occurrence of further decompensation — Time to first further decompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks) Further decompensation is defined as any of the following conditions:
1. the occurrence of a second portal hypertension driven decompensation event (ascites, variceal bleeding or HE) and/or non-obstructive jaundice;
2. the occurrence of recurrent variceal bleeding, refractory ascites, recurrent HE, SBP, and/or HRS-AKI;
3. the occurrence of ascites, HE, or jaundice in patients with bleeding alone after recovery from bleeding, according to the Baveno VII consensus.
Trial sites (1)
Facility
City
Region
Status
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang
Liaoning
More General Hospital of Shenyang Military Region trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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