Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Status Terminated

Clinical Trial Summary

Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction). This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hyponatremia

Clinical Trial Details

NCT number	NCT00727090
Study type	Interventional
Source	Northwestern University
Contact
Status	Terminated
Phase	Phase 4
Start date	August 2008
Completion date	February 2010

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Withdrawn	`NCT02667977` - Reexamining Hypotonic Intravenous Fluid Use	N/A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
Completed	`NCT02545101` - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH	N/A
Withdrawn	`NCT02442674` - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia	Phase 3
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