Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

Insel Gruppe AG, University Hospital Bern

Status and phase: Terminated; Phase 3

Conditions: Liver Cirrhosis

Treatments: Drug: Placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01311167

Dexa_Cirr_2011

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo