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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02163512

Acronym

ALB-BET

Enrollment

Registered

2014-06-13

Start date

2014-03-12

Completion date

2018-05-31

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Cirrhosis

Keywords

Hepatic cirrhosis, Ascites, Beta blockers treatment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Spain

Outcome results