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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00968695
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Grifols Therapeutics LLC ( Instituto Grifols, S.A. )

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

Condition or disease Intervention/treatment Phase
Cirrhosis Ascites Drug: Albumin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Actual Study Start Date : July 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Albutein 20%


Outcome Measures
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Primary Outcome Measures :
  1. To asses change from Baseline plasma renin concentration at Week 14 [ Time Frame: 14 weeks ]
    Plasma renin activity will be measured at Baseline and Week 14

  2. To asses change from Baseline plasma renin concentration at Week 20 [ Time Frame: 20 weeks ]
    Plasma renin activity will be measured at Baseline and Week 20

  3. To asses change from Baseline plasma concentration of noradrenaline at week 14 [ Time Frame: 14 weeks ]
    Plasma noradrenaline concentration will be measured at Baseline and Week 14

  4. To asses change from Baseline plasma concentration of noradrenaline at Week 20 [ Time Frame: 20 weeks ]
    Plasma noradrenaline concentration will be measured at Baseline and Week 20

  5. To assess change from Baseline glomerular filtration rate at Week 14 [ Time Frame: 14 weeks ]
    Glomerular filtration rate will be measured at Baseline and Week 14

  6. To assess change from Baseline glomerular filtration rate at Week 20 [ Time Frame: 20 weeks ]
    Glomerular filtration rate will be measured at Baseline and Week 20

  7. To assess change from Baseline cardiac output at Week 14 [ Time Frame: 14 weeks ]
    Cardiac output will be measured at Baseline and Week 14

  8. To assess change from Baseline cardiopulmonary pressures at Week 14 [ Time Frame: 14 weeks ]
    Cardiopulmonary pressures will be measured at Baseline and Week 14

  9. To assess change from Baseline free hepatic pressure at Week 14 [ Time Frame: 14 weeks ]
    Free hepatic pressure will be measured at Baseline and Week 14

  10. To assess change from Baseline wedged hepatic pressure at Week 14 [ Time Frame: 14 weeks ]
    Wedged hepatic pressure will be measured at Baseline and Week 14

  11. To assess change from Baseline echocardiography at Week 14 [ Time Frame: 14 weeks ]
    Echocardiography will be measured at Baseline and Week 14


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968695


Locations
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Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clínic of Barcelona
Barcelona, Spain, 08036
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Instituto Grifols, S.A.
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Vicente Arroyo, MD Hospital Clínic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT00968695    
Other Study ID Numbers: IG0802
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Ascites
 Pathologic Processes
Liver Diseases
Digestive System Diseases