Treatment of Sodium Retention in Liver Cirrhosis With Dex... | NCT01311167

Studies
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

NCT01311167

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Terminated

Last Update Posted

Apr 18, 2013Estimated

Enrollment

2Actual

Phase

Phase 3

Conditions

Liver Cirrhosis

Interventions

Dexamethasone
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment problems (not enough patients were found who met eligibility criteria)

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Mar 7, 2011

First Submission Date that Met QC Criteria

Mar 8, 2011

First Posted Date

Mar 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2013

Last Update Posted Date

Apr 18, 2013Estimated

Name	Class
University Hospital, Geneva	OTHER
University of Lausanne Hospitals	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Experimental		Drug: Dexamethasone
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Daily administration of 2 mg of dexamethasone for 4 days	Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily sodium excretion of sodium in the urine		4 days

Secondary Outcomes

Measure	Description	Time Frame
Daily potassium excretion		4 days
weight reduction		4 days
Reduction of doses of diuretics

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Inselspital		Bern	Canton of Bern	3010	Switzerland
University Hospital Geneva

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided