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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia
Baseline assessment will include a
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental | Open label study of tolvaptan. First 3 days as an inpatient then outpatient for the remainder of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | 15 to 30mg qd titrated to sodium concentration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Brain MR Spectroscopy | 14 days | |
| Brain Diffusion Tensor Imaging | 14 days | |
| Health-related Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasmohan S Bajaj, MD | Hunter Holmes McGuire VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006501 | Hepatic Encephalopathy |
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 14 days |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |