TerminatedNot Applicable

Tolvaptan for Patients With Acute Neurological Injuries

Stopped: Major protocol revision needed, current project terminated after enrollment of 25 patients.

United States25 participantsStarted 2015-08

Plain-language summary

Hyponatremia occurs frequently in patients with acute brain injury in the days to weeks following injury, and may contribute to adverse outcome. In addition, hyponatremia can aggravate neurologic dysfunction, complicate neurological assessments, and contribute to neurologic symptoms such as gait dysfunction that can impair efforts at mobilization and rehabilitation. Strict normonatremia (serum Na levels between 135 and 145 meq/dl) is the goal in most patients with acute brain injury. SIADH is the most frequent cause of hyponatremia in patients with neurological injury; however, treatment with fluid restriction is often difficult or contra-indicated, for example in patients with subarachnoid hemorrhage (SAH) where intravascular hypovolemia can trigger vasospasms. The aim of this project is to test Tolvaptan, an ADH antagonist, as a treatment in selected patients with acute brain injury who have developed SIADH.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Serum sodium level

Timeframe: 1-3 days

Trial details

NCT IDNCT02545114

SponsorPolderman, Kees, H., MD, PhD

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2016-07