Hepatic EncephalopathyNCT02177708
Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy
An observational study of Hepatic Encephalopathy, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Type C HE
Who may be able to join
- Patients with type C HE during and after HE,
- Patients with stable cirrhosis and
- Healthy subjects
Who cannot join
- Patients with pace-maker
- Metal implants
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus, 8000
Gitte Dam, MD, +4531562547, gitte_dam@hotmail.com
Gitte Dam, MD,Phd
About this study
Official title: Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy Measured by MR
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.
- Conditions
- Hepatic Encephalopathy
- Medical subject headings
- Hepatic Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute brain water content measured by water mapping
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Dam, University of Aarhus
- Investigators
- Gitte Dam, MD, Phd, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177708
- Sponsor's protocol ID
- 34781
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy Measured by MR
- ClinicalTrials.gov ID
- NCT02177708
- Acronym / sponsor ID
- 34781
- Conditions
- Hepatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type C HE
Key inclusion criteria (3 listed)
- Patients with type C HE during and after HE,
- Patients with stable cirrhosis and
- Healthy subjects
Key exclusion criteria (2 listed)
- Patients with pace-maker
- Metal implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute brain water content measured by water mapping
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
Related trials for Hepatic Encephalopathy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Cirrhosis, Portal Hypertension
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Dam, MD, Phd principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute brain water content measured by water mapping (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.