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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01311167 |
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Date of registration:
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07/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
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Scientific title:
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Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01311167 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Switzerland
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Cirrhosis
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Intervention(s)
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Drug: Placebo
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Drug: Dexamethasone
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Primary Outcome(s)
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Daily sodium excretion of sodium in the urine
[Time Frame: 4 days]
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Secondary Outcome(s)
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weight reduction
[Time Frame: 4 days]
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Daily potassium excretion
[Time Frame: 4 days]
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Reduction of cortisol levels in the urine
[Time Frame: 4 days]
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Reduction of ascites
[Time Frame: 4 days]
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Reduction of cortisol excretion in the urine
[Time Frame: 4 days]
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Reduction of doses of diuretics
[Time Frame: 4 days]
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Secondary ID(s)
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Dexa_Cirr_2011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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