Quantitative Determination of Brain Water Content in Pati... | NCT02177708

Studies
Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy

NCT02177708

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jun 30, 2014Estimated

Enrollment

45Estimated

Phase

Not provided

Conditions

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 26, 2014

First Submission Date that Met QC Criteria

Jun 26, 2014

First Posted Date

Jun 30, 2014Estimated

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

Jun 26, 2014

Last Update Posted Date

Jun 30, 2014Estimated

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

There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE patients or used indirect methods.

Methods: The investigators wish to describes quantitative measurement of localized water content using MRI water mapping in a cohort of patients with cirrhosis during an episode of overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history of HE and healthy subjects will be investigated as controls.

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

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

45Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute brain water content measured by water mapping		Patients are recruited during an episode of acute HE, the patients are rescanned within a time frame of 6 weeks. Patients with stable cirrhosis and healthy subjects are scanned only once.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with type C HE during and after HE,
Patients with stable cirrhosis and
Healthy subjects

Exclusion Criteria:

Patients with pace-maker
Metal implants

Accepts Healthy Volunteers

Yes

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

Patients with Type C HE

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gitte Dam, MD, Phd	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital	Recruiting	Aarhus	Aarhus	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006501	Hepatic Encephalopathy

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided