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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02163512
Other study ID # ALB-BET-2011-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2014
Est. completion date May 2018

Study information

Verified date June 2016
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital Universitario Gregorio Marañón Madrid
Spain Hospital Universitario Ramón y Cajal Madrid

Sponsors (1)

Lead Sponsor Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac function Echocardiography: changes in left ventricular ejection fraction, cardiac output,
Electrocardiography: changes in Qt interval
Baseline and after 4 weeks
Primary Kidney function 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 Inflammatory markers and vasoactive endogenous system 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
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