Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Information source: Northwestern University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyponatremia
Intervention: Conivaptan (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Northwestern University Official(s) and/or principal investigator(s):
Andrew M Naidech, MD, MSPH, Principal Investigator, Affiliation: Northwestern University
Overall contact:
Andrew M Naidech, MD, MSPH, Phone: 312-503-3592, Email: a-naidech@northwestern.edu
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 injury can be life-threatening and is associated with cerebral edema (swelling of
brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or
stroke (cerebral infarction).
This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater
increase in sodium than usual care. Patients will be randomly assigned to usual care or the
lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other
interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics
and salt tablets. A blinded co-investigator will record neurologic examination results (NIH
Stroke Scale and Glasgow Coma Scale).
Clinical Details
Official title: Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in serum sodium at 6, 12, 18, 24, 26 and 48 hours
Secondary outcome: NIH Stroke Scale and Glasgow Coma Scale at 24 and 48 hours
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- severe hyponatremia (Na < 130 mmol/L) or
- symptomatic hyponatremia - Na < 135 mmol/L with either change in the NIH Stroke Scale
of ≥ 2 points or change in the Glasgow Coma Scale by ≤ 1 point from baseline within 24
hours
Exclusion Criteria:
- 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
Locations and Contacts
Andrew M Naidech, MD, MSPH, Phone: 312-503-3592, Email: a-naidech@northwestern.edu
Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting
Andrew M Naidech, MD, MSPH, Phone: 312-503-3592, Email: a-naidech@northwestern.edu
Andrew M Naidech, MD, MSPH, Principal Investigator
Kenji Muro, MD, Sub-Investigator
James Paparello, MD, Sub-Investigator
Sarice L Bassin, MD, Sub-Investigator
Richard A Bernstein, MD, PhD, Sub-Investigator
Additional Information
Starting date: August 2008
Last updated: September 10, 2008
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