Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

April 17, 2013 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Inselspital
      • Geneva, Switzerland
        • University Hospital Geneva
    • Vaud
      • Lausanne, Vaud, Switzerland
        • University Hospital Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Daily administration of 2 mg of placebo for 4 days
Experimental: Dexamethasone
Drug: Dexamethasone
Daily administration of 2 mg of dexamethasone for 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily sodium excretion of sodium in the urine
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Daily potassium excretion
Time Frame: 4 days
4 days
weight reduction
Time Frame: 4 days
4 days
Reduction of doses of diuretics
Time Frame: 4 days
4 days
Reduction of ascites
Time Frame: 4 days
4 days
Reduction of cortisol excretion in the urine
Time Frame: 4 days
4 days
Reduction of cortisol levels in the urine
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University Hospital, Geneva
University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexa_Cirr_2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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