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OpenTrials
Completed

NCT Number: NCT02163512

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Gregorio Marañón, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Acronym: ALB-BET

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2014
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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