Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.

Instituto Grifols, S.A.33 enrolled

Overview

Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cirrhosis Ascites

Interventions

AlbuminDRUG

The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age above 18 years and less than 80 years. * Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound. * Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide * Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L. Exclusion Criteria: * Refractory Ascites (paracentesis requirements over 1 month. * Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule\> 5 cm or three nodules\> 3 cm). * History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt * Gastrointestinal bleeding or bacterial infection documented in the past 15 days. * Heart failure or structural heart disease. * Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy). * Moderate or severe lung chronic disease. * Transplant. * Infection with human immunodeficiency virus. * Active addiction to drugs. * Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy. * Pregnancy.

Locations (6)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clínic of Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

To asses change from Baseline plasma renin concentration at Week 14

Plasma renin activity will be measured at Baseline and Week 14

Time frame: 14 weeks

To asses change from Baseline plasma renin concentration at Week 20

Plasma renin activity will be measured at Baseline and Week 20

Time frame: 20 weeks

To asses change from Baseline plasma concentration of noradrenaline at week 14

Plasma noradrenaline concentration will be measured at Baseline and Week 14

Time frame: 14 weeks

To asses change from Baseline plasma concentration of noradrenaline at Week 20

Plasma noradrenaline concentration will be measured at Baseline and Week 20

Time frame: 20 weeks

To assess change from Baseline glomerular filtration rate at Week 14

Glomerular filtration rate will be measured at Baseline and Week 14

Time frame: 14 weeks

To assess change from Baseline glomerular filtration rate at Week 20

Glomerular filtration rate will be measured at Baseline and Week 20

Time frame: 20 weeks

To assess change from Baseline cardiac output at Week 14

Cardiac output will be measured at Baseline and Week 14

Time frame: 14 weeks

To assess change from Baseline cardiopulmonary pressures at Week 14

Cardiopulmonary pressures will be measured at Baseline and Week 14

Time frame: 14 weeks

Data from ClinicalTrials.gov

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