Using low doses of Tolvaptan to treat hyponatraemia in hospitalized patients
Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.
This study tests if giving lower doses of Tolvaptan can safely help hospitalized patients with low sodium levels caused by SIADH when regular treatments haven't worked.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06171100 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of low doses of Tolvaptan in patients with moderate to severe hyponatraemia caused by SIADH who have not responded to standard management. It focuses on patients receiving a first low dose of 7.5mg, which is below the approved minimum dose of 15mg, and assesses outcomes for those requiring a second dose. The study aims to provide evidence supporting the use of lower doses in clinical practice, potentially improving patient care in this population.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18-90 with moderate to severe hyponatraemia (sodium levels <125mmol) due to SIADH who have not responded to conservative treatments.
Not a fit: Patients under 18 years old, pregnant women, or those with hyponatraemia not related to SIADH will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more effective treatment option for patients with hyponatraemia associated with SIADH.
How similar studies have performed: This study is the largest of its kind and seeks to validate a novel approach, as there is growing evidence but limited large-scale studies on low-dose Tolvaptan for this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Georgios Dimitriadis
- Email: g.dimitriadis@nhs.net
- Phone: 00441698863091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.