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

Completed

• Conditions: Hepatic Cirrhosis

• Registration Number: NCT02163512
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-12
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Status Verified: 2016-06
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac function	Baseline and after 4 weeks	* Echocardiography: changes in left ventricular ejection fraction, cardiac output,; * Electrocardiography: changes in Qt interval
Kidney function	Baseline and after 4 weeks	* Echocardiography: Renal vascular Doppler ultrasonographic parameters (resistive index of kidney arteries); * Blood test: serum creatinine, estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease formula, IL18, KIM1, NGAL

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers and vasoactive endogenous system	Baseline and after 4 weeks	* Levels of monoaminergic systems: variations in activity of the autonomous nervous system (levels of renin, aldosterone and noradrenaline); * Immune system activation: TNF-alpha, IL 6, TNFR I y II, LBP

Trial Locations

Locations (2)

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain