Status:
TERMINATED
Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Hyponatremia
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain inj...
Eligibility Criteria
Inclusion
- severe hyponatremia (Na \< 130 mmol/L) or
- symptomatic hyponatremia - Na \< 135 mmol/L for at least six hours with Glasgow Coma Scale \< 15
Exclusion
- Enrollment in the NMH high-risk spine protocol. These patients receive large amounts of fluids, have rapid changes in electrolytes, and are typically corrected in 48 hours
- Expected death from any cause
- Known sensitivity or allergy to conivaptan
- Renal failure (baseline creatinine \> 1.5 mg/dL)
- Clinical diagnosis of hypovolemia, or by central venous pressure (CVP) \< 5 mm Hg if a central venous catheter is in place
- Concomitant use of potent inhibitors of cytochrome P-450 isoenzyme 3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir). These agents are not commonly used in the Neuro-ICU
- Clinical diagnosis of liver failure or insufficiency
- Pregnancy (must be excluded before entry)
- Lack of informed consent from the patient or a legally authorized representative (LAR)
- Use of intra-arterial vasodilators (e.g. verapamil, nicardipine) within 24 hours (e.g. for vasospasm after SAH)
- Concern by the Neuro-ICU pharmacist of a drug-drug interaction that would meaningfully impact care (the Neuro-ICU pharmacist will review the medication regimen before recruitment)
- Patients with a diagnosis of diabetes insipidus or treated with vasopressin, since these patients are already treated for abnormal free water balance
- Patients with congestive heart failure, since this is an approved use of the drug (these patients are typically not cared for in the Neuro-ICU)
- Age\<18 years (these patients are not cared for at NMH)
- Inclusion declined by the attending physician or consulting study nephrologist
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00727090
Start Date
August 1 2008
End Date
February 1 2010
Last Update
March 28 2022
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