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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
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Dexamethasone, Sodium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

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

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
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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

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Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

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