Use of Tolvaptan to Treat SIADH-induced Hyponatremia in Selected Patients With Acute Neurological Injuries
Phase: NA
Conditions: Hyponatremia, SIADH
Sponsor: Polderman, Kees, H., MD, PhD

ClinicalTrials.gov identifier: NCT02545114  
Tolvaptan for patients with acute neurological injuries. 
Main investigators: Kees H. Polderman, MD, PhD, and Brian T. Jankowitz, MD. 
 
August 24TH 2018.  
 
Study results 
Seventy-nine patients were screened, of whom 25 were enrolled; 24 of these patients had an 
admission diagnosis of subarachnoid hemorrhage, one had an intracranial hemorrhage. The 
average dose of tolvapan given was 29.4mg. Sodium levels were 130.2±1.7 before tolvaptan, 
132.3±3.4 at 12hrs, 135.4±3.1 at 24hrs, 137.2±3.5 at 48hrs, 136.1±3.4 at 72hrs, 137.8±2.9 at 
96hrs, and 137.4±3.9 at 120hrs; the median treatment duration was 9 days. Enrollment was 
discontinued when 2 patients developed polyuria, persisting after tolvaptan discontinuation and 
likely unrelated to the drug; however, we deemed our screening process insufficient in excluding 
CSW (the likely cause of polyuria) and decided to halt the current study and develop a new 
protocol with better screening for CSW. No other adverse events occurred.