Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
- Registration Number
- NCT00968695
- Lead Sponsor
- Instituto Grifols, S.A.
- Brief Summary
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Albumin Albumin The subjects will be receiving albumin 20% infusions
- Primary Outcome Measures
Name Time Method To asses change from Baseline plasma renin concentration at Week 14 14 weeks Plasma renin activity will be measured at Baseline and Week 14
To asses change from Baseline plasma renin concentration at Week 20 20 weeks Plasma renin activity will be measured at Baseline and Week 20
To asses change from Baseline plasma concentration of noradrenaline at week 14 14 weeks Plasma noradrenaline concentration will be measured at Baseline and Week 14
To asses change from Baseline plasma concentration of noradrenaline at Week 20 20 weeks Plasma noradrenaline concentration will be measured at Baseline and Week 20
To assess change from Baseline glomerular filtration rate at Week 14 14 weeks Glomerular filtration rate will be measured at Baseline and Week 14
To assess change from Baseline glomerular filtration rate at Week 20 20 weeks Glomerular filtration rate will be measured at Baseline and Week 20
To assess change from Baseline cardiac output at Week 14 14 weeks Cardiac output will be measured at Baseline and Week 14
To assess change from Baseline cardiopulmonary pressures at Week 14 14 weeks Cardiopulmonary pressures will be measured at Baseline and Week 14
To assess change from Baseline free hepatic pressure at Week 14 14 weeks Free hepatic pressure will be measured at Baseline and Week 14
To assess change from Baseline wedged hepatic pressure at Week 14 14 weeks Wedged hepatic pressure will be measured at Baseline and Week 14
To assess change from Baseline echocardiography at Week 14 14 weeks Echocardiography will be measured at Baseline and Week 14
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínic of Barcelona
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain