Status:
TERMINATED
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Otsuka America Pharmaceutical
Medical University of South Carolina
Conditions:
Brain Injury
Hyponatremia
Eligibility:
All Genders
18+ years
Brief Summary
To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute brain injured patien...
Eligibility Criteria
Inclusion
- Acute brain injury patients in the ICU with hyponatremia (Na \< 135 mmol/L) necessitating treatment in addition to fluid restriction per clinical judgement or patients at risk for worsening cerebral edema
- Informed consent obtained from patient or authorized legal representative
- Age ≥ 18 years
Exclusion
- Use of CYP3A4 inhibitors or inducers as medications, juices, or herbal supplements within 96 hours prior to the study period.
- A positive urine or serum pregnancy test, or are currently breast-feeding
- Patients with subarachnoid hemorrhage or in patients suspected to have cerebral salt wasting or any signs of volume depletion
- Imminent death or brain death
- Concomitant fungal infection
- History of HIV
- Concomitant administration of continuous infusion hypertonic saline, conivaptan or hypertonic saline bolus within 24 hours of study drug administration
- Diuretic or mannitol administration within 6 hours
- Serum creatinine ≥ 3.5 mg/dL
- Diagnosis of cirrhosis or liver function tests \> 2x the upper limit of normal
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02215148
Start Date
November 1 2014
End Date
August 1 2016
Last Update
September 8 2016
Active Locations (3)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
2
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425