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This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management.
Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First dose tolvapatan |
| ||
| Second dose tolvaptan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Oral ingestion of low dose Tolvaptan (7.5mg daily) for management of inpatient hyponatraemia for 1st dose Tolvaptan group. Oral ingestion of low dose Tolvaptan (7.5mg daily) or standard dose Tolvaptan (15mg daily) for 2nd dose Tolvaptan group. |
| Measure | Description | Time Frame |
|---|---|---|
| Response to low dose tolvaptan | Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia | Within 30 hours from tolvaptan intake |
| Safety of low dose tolvaptan | Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose | Within 30 hours from tolvaptan intake |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to hospital through Accident & Emergency department or those who developed inpatient moderate to severe refractory hyponatraemia associated with SIADH and needed treatment with Tolvaptan.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Dimitriadis | Contact | 00441698863091 | g.dimitriadis@nhs.net | |
| David Llewellyn | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital NHS Foundation Trust | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010900 | Pituitary Diseases |
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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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| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |