Tolvaptan for Patients With Acute Neurological Injuries

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02545114
• Date of registration: 02/09/2015
• Prospective Registration: No
• Primary sponsor: Polderman, Kees, H., MD, PhD
• Public title: Tolvaptan for Patients With Acute Neurological Injuries
• Scientific title: Use of Tolvaptan to Treat SIADH-induced Hyponatremia in Selected Patients With Acute Neurological Injuries
• Date of first enrolment: August 2015
• Target sample size: 25
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02545114
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Kees Polderman, MD, PhD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with euvolemic or hypervolemic hyponatremia: serum Na <135 meq/dl

- Inappropriately high urinary sodium excretion

Exclusion Criteria:

- Clinically evident hypovolemic hyponatremia

- Recent myocardial infarction or cardiac surgery

- Sustained ventricular tachycardia or fibrillation

- Systolic blood pressure of less than 90 mm Hg

- Serum creatinine concentration of more than 3 mg per deciliter

- History of, or biochemical evidence of, liver disease

- Serum sodium concentration less than 120 mmol per liter in association with neurologic
impairment

- Urinary tract obstruction

- Use of other diuretics (furosemide, burinex, hydrochlorthiazide) that cannot be safely
discontinued

- Concomitant use of hypertonic saline (prior use OK, if hypertonic is stopped within 1
hour of the first dose of Tolvaptan administration).

- History of chronic SIADH or known chronic hyponatremia from other causes (e.g. heart
failure)

- Uncontrolled hypothyroidism or adrenal insufficiency

- Severe co-morbidities with life expectancy <6 months

- CMO status



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hyponatremia

SIADH

Intervention(s)

Drug: Tolvaptan

Primary Outcome(s)

Serum sodium level [Time Frame: 1-3 days]

Secondary Outcome(s)

Incidence of vasospasms [Time Frame: 3 weeks]

Length of stay in ICU [Time Frame: 4 weeks]

Incidence of pulmonary edema [Time Frame: 2 weeks]

Secondary ID(s)

0002103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pittsburgh