NCT00968695

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

Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Ascites

Interventions

Type	Name	Description
DRUG	Albumin	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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2009-08-31
• Last updated: 2019-06-26

Locations

6 sites across 1 country: Spain