Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

This study has been terminated.
(Recruitment problems (not enough patients were found who met eligibility criteria))
Sponsor:
Collaborators:
University Hospital, Geneva
University of Lausanne Hospitals
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01311167
First received: March 7, 2011
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Liver Cirrhosis
Drug: Dexamethasone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Daily sodium excretion of sodium in the urine [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily potassium excretion [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • weight reduction [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Reduction of doses of diuretics [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Reduction of ascites [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Reduction of cortisol excretion in the urine [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Reduction of cortisol levels in the urine [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 7, 2011
Last Updated: April 17, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Dexamethasone
Sodium

Additional relevant MeSH terms:
Hypernatremia
Liver Cirrhosis
Fibrosis
Water-Electrolyte Imbalance
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014