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

Hepatic Cirrhosis Clinical Trial

— ALB-BET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163512
• Other study ID #: ALB-BET-2011-01
• Status: Completed
• Start date: March 12, 2014
• Est. completion date: May 2018

Study information

• Verified date: June 2016
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Fibrosis
• Hepatic Cirrhosis
• Liver Cirrhosis

Locations

Country	Name	City	State
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function	Echocardiography: changes in left ventricular ejection fraction, cardiac output,; Electrocardiography: changes in Qt interval	Baseline and after 4 weeks
Primary	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	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