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

NCT ID: NCT02177708

Last Updated: 2014-06-30

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

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Hepatic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Gitte Dam

MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gitte Dam, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, Aarhus, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Gitte Dam, MD

Role: primary

Other Identifiers

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34781

Identifier Type: -

Identifier Source: org_study_id