Low-dose Tolvaptan for Inpatient Hyponatraemia.

Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06171100

Enrollment

180

Registered

2023-12-14

Start date

2024-03-15

Completion date

2024-12-30

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia, SIADH

Keywords

Tolvaptan

Brief summary

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.

Interventions

DRUGTolvaptan

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Exclusion criteria

* Pregnant women and patients aged \< 18y.o * Hyponatraemia not associated with SIADH

Design outcomes

Primary

Measure	Time frame	Description
Response to low dose tolvaptan	Within 30 hours from tolvaptan intake	Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia
Safety of low dose tolvaptan	Within 30 hours from tolvaptan intake	Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose

Countries

United Kingdom

Contacts

Primary ContactGeorgios Dimitriadis

g.dimitriadis@nhs.net00441698863091

Backup ContactDavid Llewellyn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026