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Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

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ClinicalTrials.gov Identifier: NCT01311167
Recruitment Status : Terminated (Recruitment problems (not enough patients were found who met eligibility criteria))
First Posted : March 9, 2011
Last Update Posted : April 18, 2013
Sponsor:
Collaborators:
University Hospital, Geneva
University of Lausanne Hospitals
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Dexamethasone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011


Arm Intervention/treatment
Experimental: Dexamethasone Drug: Dexamethasone
Daily administration of 2 mg of dexamethasone for 4 days

Placebo Comparator: Placebo Drug: Placebo
Daily administration of 2 mg of placebo for 4 days




Primary Outcome Measures :
  1. Daily sodium excretion of sodium in the urine [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Daily potassium excretion [ Time Frame: 4 days ]
  2. weight reduction [ Time Frame: 4 days ]
  3. Reduction of doses of diuretics [ Time Frame: 4 days ]
  4. Reduction of ascites [ Time Frame: 4 days ]
  5. Reduction of cortisol excretion in the urine [ Time Frame: 4 days ]
  6. Reduction of cortisol levels in the urine [ Time Frame: 4 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311167


Locations
Switzerland
University Hospital Lausanne
Lausanne, Vaud, Switzerland
University Hospital Inselspital
Bern, Switzerland, 3010
University Hospital Geneva
Geneva, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
University Hospital, Geneva
University of Lausanne Hospitals

Responsible Party: National Center of Competence Kidney.CH, Swiss National Foundation
ClinicalTrials.gov Identifier: NCT01311167     History of Changes
Other Study ID Numbers: Dexa_Cirr_2011
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013

Keywords provided by University Hospital Inselspital, Berne:
Dexamethasone
Sodium

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Hypernatremia
Pathologic Processes
Liver Diseases
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action