Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: University Hospital, Geneva; University of Lausanne Hospitals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• patients with established liver cirrhosis (biopsy or biochemically)

• hepatorenal syndrome type 1 or 2 (with a serum creatinin >175 umol/l)

• age between 18 and 75

• no bacterial infection

• no cardiovascular or extrahepatic disease (end of life)

• no structural kidney disease

• no hepatocellular carcinoma

Exclusion Criteria:

• age under 15 or over 75

• treatment with corticosteroids (dexamethasone included)

• bacterial infection

• cardiovascular or extrahepatic disease (end of life)

• structural kidney disease (indicated by hematuria, proteinuria)

• hepatocellular carcinoma

• mental disability