Low-dose Tolvaptan for Inpatient Hyponatraemia.

Recruiting

• Conditions: Hyponatremia; SIADH
• Interventions: Drug: Tolvaptan

• Registration Number: NCT06171100
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Study Start: 2024-03-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Second dose tolvaptan	Tolvaptan	-
First dose tolvapatan	Tolvaptan	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom