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.

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

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Ascites
• Intervention / Treatment: Drug: Albumin

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañón
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin; The subjects will be receiving albumin 20% infusions	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.; Other Names: Albutein 20%

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Grifols, S.A.
• Collaborators: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Vicente Arroyo, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 28, 2009
• First Submitted That Met QC Criteria: August 28, 2009
• First Posted (Estimate): August 31, 2009

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: IG0802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No