Clinical trial NCT02163512: Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites
Official title: Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Cirrhosis
Keywords: Hepatic cirrhosis
Ascites
Beta blockers treatment
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hepatic cirrhoris and refractory or non-refractory ascites. These patients are going to be treated with beta blockers as primary or secondary prophylaxis of variceal bleeding

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.


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 \>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.

Primary outcomes:
measure: Cardiac function
timeFrame: Baseline and after 4 weeks
measure: Kidney function
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Inflammatory markers and vasoactive endogenous system
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References:
citation: Tellez L, Ibanez-Samaniego L, Perez Del Villar C, Yotti R, Martinez J, Carrion L, Rodriguez de Santiago E, Rivera M, Gonzalez-Mansilla A, Pastor O, Bermejo J, Banares R, Albillos A. Non-selective beta-blockers impair global circulatory homeostasis and renal function in cirrhotic patients with refractory ascites. J Hepatol. 2020 Dec;73(6):1404-1414. doi: 10.1016/j.jhep.2020.05.011. Epub 2020 May 21.