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Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial
Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia
Baseline assessment will include a 1. battery of eight cognitive tests 2. Health related quality of life 3. MRI head evaluating MR spectroscopy and diffusion tensor imaging Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed. Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between. Participation will be terminated in case patients get transplanted or develop overt HE in between.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Start Date
April 1, 2011
Primary Completion Date
June 1, 2013
Completion Date
June 1, 2013
Last Updated
February 7, 2014
25
ACTUAL participants
Tolvaptan
DRUG
Lead Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
NCT05597488
NCT06932783
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06306963