Status:

UNKNOWN

Prevention of Decompensation in Liver Cirrhosis

Lead Sponsor:

Odense University Hospital

Collaborating Sponsors:

Lundbeck Foundation

University of Southern Denmark

Conditions:

Alcoholic Liver Cirrhosis

Ascites

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover i...

Detailed Description

Patients with cirrhosis tend to retain sodium and water leading to the development of ascites, which in the terminal stage of decompensation cannot be eliminated despite the use of massive diuretic tr...

Eligibility Criteria

Inclusion

  • The presence of cirrhosis in a liver biopsy; or, in the absence of histology, clinical and laboratory evidence of cirrhosis combined with years of excessive alcohol intake.
  • Age 18-70 years

Exclusion

  • Cirrhosis due to alpha1-antitrypsin deficiency, viral hepatitis or autoimmunity.
  • Renal disease evidenced by proteinuria \> 0,5 g/day.
  • Heart disease
  • Hypertension
  • Cancer or disease other than cirrhosis expected to limit life expectancy to \< 5 years.
  • Pregnancy or lactation
  • Sepsis within 5 days
  • Gastrointestinal bleeding within 5 days

Key Trial Info

Start Date :

September 1 2005

Trial Type :

INTERVENTIONAL

End Date :

September 1 2011

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00239096

Start Date

September 1 2005

End Date

September 1 2011

Last Update

October 14 2005

Active Locations (1)

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Odense University Hospital

Odense, Odense, Denmark, 5000