Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

Liver Cirrhosis Clinical Trial

Official title:

Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01311167
• Other study ID #: Dexa_Cirr_2011
• Status: Terminated
• Phase: Phase 3
• First received: March 7, 2011
• Last updated: April 17, 2013
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2013
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypernatremia
• Liver Cirrhosis

Intervention

Drug:
• Dexamethasone
Daily administration of 2 mg of dexamethasone for 4 days
• Placebo
Daily administration of 2 mg of placebo for 4 days

Locations

Country	Name	City	State
Switzerland	University Hospital Inselspital	Bern
Switzerland	University Hospital Geneva	Geneva
Switzerland	University Hospital Lausanne	Lausanne	Vaud

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University Hospital, Geneva, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily sodium excretion of sodium in the urine		4 days	No
Secondary	Daily potassium excretion		4 days	No
Secondary	weight reduction		4 days	No
Secondary	Reduction of doses of diuretics		4 days	No
Secondary	Reduction of ascites		4 days	No
Secondary	Reduction of cortisol excretion in the urine		4 days	No
Secondary	Reduction of cortisol levels in the urine		4 days	No