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

February 8, 2019 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non-refractory ascites
Refractory ascites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: Baseline and after 4 weeks
  • Echocardiography: changes in left ventricular ejection fraction, cardiac output,
  • Electrocardiography: changes in Qt interval
Baseline and after 4 weeks
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
Baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers and vasoactive endogenous system
Time Frame: 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
Baseline and after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALB-BET-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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