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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.

This study is currently recruiting participants.
Verified November 2012 by Instituto Grifols, S.A.
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Joan Albert Arnaiz, Instituto Grifols, S.A.
ClinicalTrials.gov Identifier:
NCT00968695
First received: August 28, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cirrhosis
Ascites
 Drug: Albumin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Grifols, S.A.:

Primary Outcome Measures:
  • To asses plasma renin activity and plasma concentration of noradrenaline [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Glomerular filtration [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Portal hypertension [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Cardiac Function [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albumin Drug: Albumin
The pattern of administration of 20% human albumin is 1'5g/kg every week to infuse in 6 hours with a minimum of 90 g up to 150 g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, BUN ≥ 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968695

Contacts
Contact: Joan Albert Arnaiz, MD 0034932279838 jaarnaiz@clinic.ub.es
Contact: Laura Núnez, M Sc 0034935710700 laura.nunez@grifols.com

Locations
Spain
Hospital Universitari Germans Trias i Pujol Active, not recruiting
Badalona, Barcelona, Spain, 08916
Hospital Clínic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Vicente Arroyo, MD     0034932275739     varroyo@clinic.ub.es    
Contact: Javier Fernández, MD     0034932275739     ffernanr@clinic.ub.es    
Hospital de la Santa Creu i Sant Pau Active, not recruiting
Barcelona, Spain, 08025
Hospital del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Luis Ruiz del Árbol, MD            
Hospital Universitario Gregorio Marañón Active, not recruiting
Madrid, Spain, 28007
Sponsors and Collaborators
Joan Albert Arnaiz
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Vicente Arroyo, MD Hospital Clínic of Barcelona
  More Information

No publications provided

Responsible Party: Joan Albert Arnaiz, Project manager, Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT00968695     History of Changes
Other Study ID Numbers: IG0802
Study First Received: August 28, 2009
Last Updated: November 6, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013