Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites (ALB-BET)

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: Hepatic Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT02163512

ALB-BET-2011-01

Details and patient eligibility

About

Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-80
• Patients previously prescribed with beta-blockers
• Any type of hepatic cirrosis that has been diagnosed by clinical, analytic and image criteria
• Mild to serious ascites. Classification on refractory or non-refractory ascites depends on the patient´s response to diuretic treatment. Refractory ascites is defined by the Ascites´Board International Criteria as the lack of response, ascites recurrency or complications occurrence by diuretic drugs uptake
• Esophageal varicose vein in which beta blockers treatment is indicated as primary or secondary prophylaxis. Primary prophylaxis is indicated for big esophageal varicose veins, small varicose veins with red signs or varicose veins in patients with B-C Child-Pugh stage. Secondary prophylaxis is indicated for all those patients that have previously presented varicose bleeding.
• Patients giving a written consent to participate in the study after having received enough information about the design, objectives and risks.

Exclusion criteria

• Hepatocellular carcinoma >5 cm
• Total portal vein thrombosis or Cavernous transformation of the portal vein
• Insuficiencia renal (creatinina sérica >3 mg/dl).
• Kidney insufficiency (seric creatinine >3 mg/dl)
• Contraindications to beta-blockers: Cardiac or breathing insufficiency, auricular-ventricular blocking grade >1.
• Anticoagulant treatment
• Patients with a intrahepatic portosystemic shunt
• Beta-blockers Hypersensitivity
• Pregnancy and breastfeeding
• Women of childbearing age must commit to undergo an effective contraception during the treatment and at least one month after finishing it.
• Patients with severe controlled or not controlled psychiatric condition
• Patients´ lack of commitment to follow all visits.

Trial design

46 participants in 2 patient groups

Non-refractory ascites

Refractory ascites