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

Primary Purpose

Cirrhosis, Ascites

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Albumin
Sponsored by
Instituto Grifols, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol
  • Hospital del Mar
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clínic of Barcelona
  • Hospital Universitario Gregorio Marañón
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Albumin

Arm Description

The subjects will be receiving albumin 20% infusions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 28, 2009
Last Updated
June 24, 2019
Sponsor
Instituto Grifols, S.A.
Collaborators
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00968695
Brief Title
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Grifols, S.A.
Collaborators
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 with advanced cirrhosis and ascites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albumin
Arm Type
Experimental
Arm Description
The subjects will be receiving albumin 20% infusions
Intervention Type
Drug
Intervention Name(s)
Albumin
Other Intervention Name(s)
Albutein 20%
Intervention Description
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.
Primary Outcome Measure Information:
Title
To asses change from Baseline plasma renin concentration at Week 14
Description
Plasma renin activity will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To asses change from Baseline plasma renin concentration at Week 20
Description
Plasma renin activity will be measured at Baseline and Week 20
Time Frame
20 weeks
Title
To asses change from Baseline plasma concentration of noradrenaline at week 14
Description
Plasma noradrenaline concentration will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To asses change from Baseline plasma concentration of noradrenaline at Week 20
Description
Plasma noradrenaline concentration will be measured at Baseline and Week 20
Time Frame
20 weeks
Title
To assess change from Baseline glomerular filtration rate at Week 14
Description
Glomerular filtration rate will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To assess change from Baseline glomerular filtration rate at Week 20
Description
Glomerular filtration rate will be measured at Baseline and Week 20
Time Frame
20 weeks
Title
To assess change from Baseline cardiac output at Week 14
Description
Cardiac output will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To assess change from Baseline cardiopulmonary pressures at Week 14
Description
Cardiopulmonary pressures will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To assess change from Baseline free hepatic pressure at Week 14
Description
Free hepatic pressure will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To assess change from Baseline wedged hepatic pressure at Week 14
Description
Wedged hepatic pressure will be measured at Baseline and Week 14
Time Frame
14 weeks
Title
To assess change from Baseline echocardiography at Week 14
Description
Echocardiography will be measured at Baseline and Week 14
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Arroyo, MD
Organizational Affiliation
Hospital Clínic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30905652
Citation
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.
Results Reference
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Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.

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