Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

NCT ID: NCT01311167

Last Updated: 2013-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Daily administration of 2 mg of dexamethasone for 4 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily administration of 2 mg of placebo for 4 days

Interventions

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Dexamethasone

Daily administration of 2 mg of dexamethasone for 4 days

Intervention Type DRUG

Placebo

Daily administration of 2 mg of placebo for 4 days

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Swiss National Foundation

Locations

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University Hospital Inselspital

Bern, Canton of Bern, Switzerland

Site Status

University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Site Status

University Hospital Lausanne

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Dexa_Cirr_2011

Identifier Type: -

Identifier Source: org_study_id

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