Effect of Tolvaptan on Cognitive Function in Cirrhosis

Cirrhosis Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy
• Hyponatremia
• Liver Cirrhosis

• NCT number: NCT01556646
• Study type: Interventional
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Status: Completed
• Phase: Phase 3
• Start date: April 2011
• Completion date: June 2013