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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-12

Study Completion Date

2018-05-31

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.

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Detailed Description

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Conditions

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Hepatic Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-refractory ascites

No interventions assigned to this group

Refractory ascites

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No