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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatic Cirrhosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-refractory ascites<br> | |
| Refractory ascites<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function | Echocardiography: changes in left ventricular ejection fraction, cardiac output, Electrocardiography: changes in Qt interval | Baseline and after 4 weeks | 
| Kidney function | 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 | Baseline and after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers and vasoactive endogenous system | 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 | Baseline and after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic cirrhosis, Ascites, Beta blockers treatment