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Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological 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: NCT00684164
Recruitment Status : Withdrawn (Unable to complete a contract with the Sponsor)
First Posted : May 26, 2008
Last Update Posted : March 6, 2015
Astellas Pharma Inc
Information provided by:
Columbia University

Brief Summary:

Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body.

FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.

Condition or disease Intervention/treatment Phase
Hyponatremia Drug: Conivaptan Other: D5 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients
Study Start Date : May 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Subjects in the treatment group will receive standard medical treatment plus Conivaptan administered as a 20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached.
Drug: Conivaptan
20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days
Other Name: VAPRISOL

Placebo Comparator: 2
Subjects in the placebo control group will receive an equivalent volume loading dose of D5 followed by an infusion of D5 in the same manner as the experimental group.
Other: D5
Volume loading dose of D5 followed by an infusion of D5 over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached.

Primary Outcome Measures :
  1. Mean change in serum sodium over the duration of treatment between the two treatment arms. [ Time Frame: From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment ]

Secondary Outcome Measures :
  1. Percentage of patients requiring study drug discontinuation for any reason other than reaching the sodium endpoint, including those with too rapid a rise in serum sodium (>12 mEq rise over 24 hours) or an infusion site reaction [ Time Frame: From the initiation of treatment to the end of treatment, up to 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute neurological injury
  • Euvolemia or hypervolemia (defined clinically by examination, recent I+Os, BUN/creatinine ratio and CVP [if available])
  • Serum sodium less than or equal to 132 mEq/L (confirmed as hypoosmolar hyponatremia by a concurrent source: osmolality measurements [<280 mosoms/L] or by a preceding serum Na+ value <135 mEq/L0

Exclusion Criteria:

  • Patients who have uncontrolled hypertension; significant orthostatic hypotension or supine systolic blood pressure less than 85 mm Hg;
  • Uncontrolled arrhythmias;
  • Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency;
  • Estimated creatinine clearance less than 20 ml/min;
  • Urinary outflow obstruction unless catheterized;
  • Alanine aminotransferase (ALT) >3x ULN
  • Aspartate aminotransferase (AST) >3x ULN
  • Serum albumin of 1.5 g/dl or less;
  • Prothrombin time greater than 22 sec or an international normalized ratio (INR) greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy; a white blood cell count less than 3000/µl;
  • HIV infection;
  • Active hepatitis.
  • Pregnant or nursing
  • Participation in a clinical trial of an investigational drug or device within 30 days of screening
  • Unable to obtain written consent

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): NCT00684164

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Astellas Pharma Inc
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Principal Investigator: Stephan A. Mayer, MD Columbia University
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Responsible Party: Stephan A. Mayer, MD, Columbia University Medical Center Identifier: NCT00684164    
Other Study ID Numbers: AAAC6833
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Columbia University:
Euvolemic Hyponatremia
Hypervolemic Hyponatremia
Neurological injury
Additional relevant MeSH terms:
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Water-Electrolyte Imbalance
Metabolic Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs