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

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Grifols

Status and phase

Completed
Phase 4

Conditions

Cirrhosis
Ascites

Treatments

Drug: Albumin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00968695
IG0802

Details and patient eligibility

About

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

Full 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.

Enrollment

33 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Albumin
Experimental group
Description:
The subjects will be receiving albumin 20% infusions
Treatment:
Drug: Albumin

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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