Status:
COMPLETED
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
Lead Sponsor:
Instituto Grifols, S.A.
Collaborating Sponsors:
Hospital Clinic of Barcelona
Conditions:
Cirrhosis
Ascites
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00968695
Start Date
July 1 2009
End Date
April 1 2014
Last Update
June 26 2019
Active Locations (6)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital del Mar
Barcelona, Spain, 08003
3
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
4
Hospital Clínic of Barcelona
Barcelona, Spain, 08036