Tolvaptan for Patients With Acute Neurological Injuries

Stopped early · Not applicable

Conditions studied: Hyponatremia, SIADH

In brief

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.

Key facts

Study ID

NCT02545114

Run by

Polderman, Kees, H., MD, PhD

People needed

25

Starts

2015-08-01

Expected to finish

2016-09-01

Last updated by the study team

2018-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with euvolemic or hypervolemic hyponatremia: serum Na <135 meq/dl
• Inappropriately high urinary sodium excretion

You may not qualify if…

• 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

Where it is running

• Mercy Hospital — Pittsburgh, Pennsylvania, United States
• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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