Low-dose Tolvaptan for Inpatient Hyponatraemia.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06171100
Study type	Observational
Source	King's College Hospital NHS Trust
Contact	Georgios Dimitriadis
Phone	00441698863091
Email	g.dimitriadis@nhs.net
Status	Recruiting
Phase
Start date	March 15, 2024
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06037928` - Plasma Sodium and Sodium Administration in the ICU
Recruiting	`NCT04561531` - Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.	N/A
Terminated	`NCT02012959` - Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia	Phase 3
Recruiting	`NCT02936167` - Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children	N/A
Completed	`NCT00621348` - Maintenance Intravenous Fluids in Children	Phase 3
Terminated	`NCT03703713` - Colloid Osmotic Pressure and Osmolality in Hyponatremia
Completed	`NCT02926989` - Intravenous Fluids in Hospitalised Children	Phase 4
Terminated	`NCT02959411` - Tolvaptan for Advanced or Refractory Heart Failure	Phase 4
Completed	`NCT02573077` - An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Withdrawn	`NCT02667977` - Reexamining Hypotonic Intravenous Fluid Use	N/A
Terminated	`NCT01708811` - Hyponatremia and Myometrium Contractility. An Invitro Study	N/A
Withdrawn	`NCT01326429` - Frequency and Origin of Dysnatremias in the Emergency Department	N/A
Completed	`NCT01456533` - Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients	N/A
Terminated	`NCT01227512` - Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia	Phase 3
Recruiting	`NCT06013800` - Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Terminated	`NCT04020926` - Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
Withdrawn	`NCT02442674` - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia	Phase 3
Completed	`NCT02545101` - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH	N/A
Terminated	`NCT02215148` - Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients	N/A
Recruiting	`NCT01748331` - The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia	N/A