Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Brain Injury Hyponatremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain injured patients with hyponatremia

Patients with acute brain injury who develop hyponatremia and are administered tolvaptan via the nasogastric tube, deemed necessary by the primary medical team.

Tolvaptan

Intervention Type DRUG

Interventions

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Tolvaptan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No