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

Cirrhosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968695
• Other study ID #: IG0802
• Status: Completed
• Phase: Phase 4
• Start date: July 2009
• Est. completion date: April 2014

Study information

• Verified date: June 2019
• Source: Grifols Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic of Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses change from Baseline plasma renin concentration at Week 14	Plasma renin activity will be measured at Baseline and Week 14	14 weeks
Primary	To asses change from Baseline plasma renin concentration at Week 20	Plasma renin activity will be measured at Baseline and Week 20	20 weeks
Primary	To asses change from Baseline plasma concentration of noradrenaline at week 14	Plasma noradrenaline concentration will be measured at Baseline and Week 14	14 weeks
Primary	To asses change from Baseline plasma concentration of noradrenaline at Week 20	Plasma noradrenaline concentration will be measured at Baseline and Week 20	20 weeks
Primary	To assess change from Baseline glomerular filtration rate at Week 14	Glomerular filtration rate will be measured at Baseline and Week 14	14 weeks
Primary	To assess change from Baseline glomerular filtration rate at Week 20	Glomerular filtration rate will be measured at Baseline and Week 20	20 weeks
Primary	To assess change from Baseline cardiac output at Week 14	Cardiac output will be measured at Baseline and Week 14	14 weeks
Primary	To assess change from Baseline cardiopulmonary pressures at Week 14	Cardiopulmonary pressures will be measured at Baseline and Week 14	14 weeks
Primary	To assess change from Baseline free hepatic pressure at Week 14	Free hepatic pressure will be measured at Baseline and Week 14	14 weeks
Primary	To assess change from Baseline wedged hepatic pressure at Week 14	Wedged hepatic pressure will be measured at Baseline and Week 14	14 weeks
Primary	To assess change from Baseline echocardiography at Week 14	Echocardiography will be measured at Baseline and Week 14	14 weeks