Tolvaptan for Patients With Acute Neurological Injuries
Status:
Terminated
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Polderman, Kees, H., MD, PhD University of Pittsburgh