Low-dose Tolvaptan for Inpatient Hyponatraemia.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Hyponatremia SIADH

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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First dose tolvapatan

Tolvaptan

Intervention Type 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.

Second dose tolvaptan

Tolvaptan

Intervention Type 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.

Interventions

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Tolvaptan

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients presenting to Accident \& Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: \<125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management.
* Patients of all genders aged 18-90 y.o