Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727090
Recruitment Status : Terminated (Enrollment below goal.)
First Posted : August 1, 2008
Results First Posted : September 27, 2010
Last Update Posted : May 6, 2013
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University

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 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 or disease Intervention/treatment Phase
Hyponatremia Drug: Conivaptan Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Study Start Date : August 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Serum Sodium From Baseline to 6 Hours [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. NIH Stroke Scale [ Time Frame: 48 hours ]
    Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).

  2. Glasgow Coma Scale [ Time Frame: 48 hours ]
    Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)

Other Outcome Measures:
  1. Change in Serum Sodium From Baseline to 12 Hours [ Time Frame: 12 hours ]
  2. Change in Serum Sodium From Baseline to 18 Hours [ Time Frame: 18 hours ]
  3. Change in Serum Sodium From Baseline to 24 Hours [ Time Frame: 24 hours ]
  4. Change in Serum Sodium From Baseline to 36 Hours [ Time Frame: 36 hours ]
  5. Change in Serum Sodium From Baseline to 48 Hours [ Time Frame: 48 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727090

Sponsors and Collaborators
Northwestern University
Astellas Pharma US, Inc.
Layout table for investigator information
Principal Investigator: Andrew M Naidech, MD, MSPH Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrew Naidech, Associate Professor, Northwestern University Identifier: NCT00727090     History of Changes
Other Study ID Numbers: 1507-10
First Posted: August 1, 2008    Key Record Dates
Results First Posted: September 27, 2010
Last Update Posted: May 6, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Water-Electrolyte Imbalance
Metabolic Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs