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

This study has been terminated.
(Enrollment below goal.)
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University
ClinicalTrials.gov Identifier:
NCT00727090
First received: July 30, 2008
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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 4

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
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)


Other Outcome Measures:
  • Change in Serum Sodium From Baseline to 12 Hours [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Change in Serum Sodium From Baseline to 18 Hours [ Time Frame: 18 hours ] [ Designated as safety issue: No ]
  • Change in Serum Sodium From Baseline to 24 Hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Change in Serum Sodium From Baseline to 36 Hours [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Change in Serum Sodium From Baseline to 48 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (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):

Responsible Party: Andrew Naidech, Associate Professor, 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: April 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013