Brain Energy Metabolism in Patients With Chronic Liver Di... | NCT00424957

Studies
Brain Energy Metabolism in Patients With Chronic Liver Disease and Impaired Central Nervous System

NCT00424957

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

18Estimated

Phase

Not provided

Conditions

Cirrhosis
Hepatic Encephalopathy

Interventions

Not provided

Countries

Denmark

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 19, 2007

First Submission Date that Met QC Criteria

Jan 19, 2007

First Posted Date

Jan 22, 2007Estimated

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

Feb 4, 2009

Last Update Posted Date

Feb 5, 2009Estimated

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

The purpose of the current study is to look into the pathogenesis of a severe medical condition causing acute episodes on the central nervous system as seen in majority of patients with liver cirrhosis.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy,
6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy,
6 healthy subjects age and sex matched

Exclusion Criteria:

Neurological and/or psychiatric condition,
Non-treated diabetes,
Pregnancy/breast-feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy, 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy, 6 healthy subjects age and sex matched

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanne Keiding, MD	PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PET Centre, Aarhus University Hospital		Aarhus		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15921824	Background	Ott P, Clemmesen O, Larsen FS. Cerebral metabolic disturbances in the brain during acute liver failure: from hyperammonemia to energy failure and proteolysis. Neurochem Int. 2005 Jul;47(1-2):13-8. doi: 10.1016/j.neuint.2005.04.002.

ID	Term
D005355	Fibrosis
D006501	Hepatic Encephalopathy

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017093	Liver Failure
D048550	Hepatic Insufficiency