NCT01556646

Effect of Tolvaptan on Cognitive Function in Cirrhosis

Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia

Detailed description

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.

Conditions

• Cirrhosis
• Hepatic Encephalopathy
• Hyponatremia

Interventions

Type	Name	Description
DRUG	Tolvaptan	15 to 30mg qd titrated to sodium concentration

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-03-16
• Last updated: 2014-02-07

Locations

1 site across 1 country: United States