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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Grifols, S.A.; Joan Albert Arnaiz
• Collaborator: Hospital Clinic of Barcelona

Criteria

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.