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

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ClinicalTrials.gov Identifier: NCT02163512
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Condition or disease
Hepatic Cirrhosis

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites
Actual Study Start Date : March 12, 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Non-refractory ascites
Refractory ascites



Primary Outcome Measures :
  1. Cardiac function [ Time Frame: Baseline and after 4 weeks ]
    • Echocardiography: changes in left ventricular ejection fraction, cardiac output,
    • Electrocardiography: changes in Qt interval

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163512


Locations
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Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02163512    
Other Study ID Numbers: ALB-BET-2011-01
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: June 2016
Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
Hepatic cirrhosis
Ascites
Beta blockers treatment
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases