Skip to content

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01311167
Enrollment
2
Registered
2011-03-09
Start date
2011-02-28
Completion date
2011-11-30
Last updated
2013-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Dexamethasone, Sodium

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.

Interventions

DRUGDexamethasone

Daily administration of 2 mg of dexamethasone for 4 days

DRUGPlacebo

Daily administration of 2 mg of placebo for 4 days

Sponsors

University Hospital, Geneva
CollaboratorOTHER
University of Lausanne Hospitals
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Daily sodium excretion of sodium in the urine4 days

Secondary

MeasureTime frame
weight reduction4 days
Reduction of doses of diuretics4 days
Daily potassium excretion4 days
Reduction of cortisol excretion in the urine4 days
Reduction of cortisol levels in the urine4 days
Reduction of ascites4 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026