Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
Primary Purpose
Liver Cirrhosis
Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Dexamethasone, Sodium
Eligibility 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
Sites / Locations
- University Hospital Lausanne
- University Hospital Inselspital
- University Hospital Geneva
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Daily sodium excretion of sodium in the urine
Secondary Outcome Measures
Daily potassium excretion
weight reduction
Reduction of doses of diuretics
Reduction of ascites
Reduction of cortisol excretion in the urine
Reduction of cortisol levels in the urine
Full Information
NCT ID
NCT01311167
First Posted
March 7, 2011
Last Updated
April 17, 2013
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University Hospital, Geneva, University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01311167
Brief Title
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
Official Title
Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems (not enough patients were found who met eligibility criteria)
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University Hospital, Geneva, University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Dexamethasone, Sodium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Daily administration of 2 mg of dexamethasone for 4 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily administration of 2 mg of placebo for 4 days
Primary Outcome Measure Information:
Title
Daily sodium excretion of sodium in the urine
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Daily potassium excretion
Time Frame
4 days
Title
weight reduction
Time Frame
4 days
Title
Reduction of doses of diuretics
Time Frame
4 days
Title
Reduction of ascites
Time Frame
4 days
Title
Reduction of cortisol excretion in the urine
Time Frame
4 days
Title
Reduction of cortisol levels in the urine
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Lausanne
City
Lausanne
State/Province
Vaud
Country
Switzerland
Facility Name
University Hospital Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital Geneva
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
We'll reach out to this number within 24 hrs