- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311167
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
-
-
-
Bern, Switzerland, 3010
- University Hospital Inselspital
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Geneva, Switzerland
- University Hospital Geneva
-
-
Vaud
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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
|
Daily administration of 2 mg of placebo for 4 days
|
Experimental: 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.
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
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Liver Diseases
- Water-Electrolyte Imbalance
- Fibrosis
- Liver Cirrhosis
- Hypernatremia
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
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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