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.
Study Type
OBSERVATIONAL
Enrollment
180
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.
King's College Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGResponse to low dose tolvaptan
Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia
Time frame: Within 30 hours from tolvaptan intake
Safety of low dose tolvaptan
Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose
Time frame: Within 30 hours from tolvaptan intake
David Llewellyn
CONTACT
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