Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients - Full Text View

Sponsor:	Northwestern University
Collaborator:	Astellas Pharma US, Inc.
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00727090

Purpose

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).

Condition	Intervention	Phase
Hyponatremia	Drug: Conivaptan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Resource links provided by NLM:

MedlinePlus related topics: Coma

Drug Information available for: YM 087 Conivaptan

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Change in Serum Sodium From Baseline to 6 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

NIH Stroke Scale [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).
Glasgow Coma Scale [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)

Enrollment:	6
Study Start Date:	August 2008
Study Completion Date:	February 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Conivaptan in addition to usual care at the discretion of the attending medical staff	Drug: Conivaptan Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours Other Name: Vaprisol
No Intervention: 2 Usual care by the attending physician staff

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

severe hyponatremia (Na < 130 mmol/L) or
symptomatic hyponatremia - Na < 135 mmol/L for at least six hours with Glasgow Coma Scale < 15

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727090

Sponsors and Collaborators

Northwestern University

Astellas Pharma US, Inc.

Investigators

Principal Investigator:

Andrew M Naidech, MD, MSPH

Northwestern University

More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Naidech AM, Paparello J, Leibling SM, Bassin SL, Levasseur K, Alberts MJ, Bernstein RA, Muro K. Use of Conivaptan (Vaprisol) for hyponatremic neuro-ICU patients. Neurocrit Care. 2010 Aug;13(1):57-61.

Responsible Party:	Andrew Naidech, Northwestern University
ClinicalTrials.gov Identifier:	NCT00727090 History of Changes
Other Study ID Numbers:	1507-10
Study First Received:	July 30, 2008
Results First Received:	July 21, 2010
Last Updated:	September 27, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on February 09, 2012