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Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

Phase 3
Terminated
Conditions
Liver Cirrhosis
Interventions
Drug: Dexamethasone
Drug: Placebo
Registration Number
NCT01311167
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DexamethasoneDexamethasone-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Daily sodium excretion of sodium in the urine4 days
Secondary Outcome Measures
NameTimeMethod
Daily potassium excretion4 days
weight reduction4 days
Reduction of doses of diuretics4 days
Reduction of ascites4 days
Reduction of cortisol excretion in the urine4 days
Reduction of cortisol levels in the urine4 days

Trial Locations

Locations (3)

University Hospital Lausanne

🇨🇭

Lausanne, Vaud, Switzerland

University Hospital Inselspital

🇨🇭

Bern, Switzerland

University Hospital Geneva

🇨🇭

Geneva, Switzerland

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