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Completed

NCT Number: NCT00968695

Effects of Long Term Albumin 20% Administration in 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.

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Key information

Conditions

Cirrhosis Ascites Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALBUMIN

Drug

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%

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Grifols, S.A.

Industry

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 31, 2009
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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