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NCT02177708 Clinical Trial

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

Hepatic Encephalopathy Clinical Trial

Official title:
Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy Measured by MR

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02177708
Other study ID # 34781
Secondary ID
Status Recruiting
Phase N/A
First received June 26, 2014
Last updated June 26, 2014
Start date January 2014
Est. completion date December 2015

Study information
Verified date June 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date December 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
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