Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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 patients

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Barnes-Jewish Hospital; Medical University of South Carolina; Otsuka America Pharmaceutical
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

1. 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

2. Informed consent obtained from patient or authorized legal representative

3. Age ≥ 18 years

Exclusion Criteria:

1. Use of CYP3A4 inhibitors or inducers as medications, juices, or herbal supplements within 96 hours prior to the study period.

2. A positive urine or serum pregnancy test, or are currently breast-feeding

3. Patients with subarachnoid hemorrhage or in patients suspected to have cerebral salt wasting or any signs of volume depletion

4. Imminent death or brain death

5. Concomitant fungal infection

6. History of HIV

7. Concomitant administration of continuous infusion hypertonic saline, conivaptan or hypertonic saline bolus within 24 hours of study drug administration

8. Diuretic or mannitol administration within 6 hours

9. Serum creatinine ≥ 3.5 mg/dL

10. Diagnosis of cirrhosis or liver function tests > 2x the upper limit of normal