Study Stopped
Recruitment problems (not enough patients were found who met eligibility criteria)
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis
1 other identifier
interventional
2
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2011
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedApril 18, 2013
April 1, 2013
9 months
March 7, 2011
April 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily sodium excretion of sodium in the urine
4 days
Secondary Outcomes (6)
Daily potassium excretion
4 days
weight reduction
4 days
Reduction of doses of diuretics
4 days
Reduction of ascites
4 days
Reduction of cortisol excretion in the urine
4 days
- +1 more secondary outcomes
Study Arms (2)
Dexamethasone
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- University Hospital, Genevacollaborator
- University of Lausanne Hospitalscollaborator
Study Sites (3)
University Hospital Inselspital
Bern, Canton of Bern, 3010, Switzerland
University Hospital Geneva
Geneva, Canton of Geneva, Switzerland
University Hospital Lausanne
Lausanne, Canton of Vaud, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 9, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
April 18, 2013
Record last verified: 2013-04