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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal2 sites in 1 country46 target enrollmentMarch 12, 2014

ConditionsHepatic Cirrhosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatic Cirrhosis
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Enrollment: 46
Locations: 2
Primary Endpoint: Cardiac function
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 12, 2014

End Date

May 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Responsible Party

Sponsor

Eligibility Criteria

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 \>
•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.

Outcomes

Primary Outcomes

Cardiac function

Time Frame: Baseline and after 4 weeks

* Echocardiography: changes in left ventricular ejection fraction, cardiac output, * Electrocardiography: changes in Qt interval

Kidney function

Time Frame: 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