Tolvaptan for Patients With Acute Neurological Injuries (NCT02545114) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.