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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.
 
ClinicalTrials.gov Identifier: NCT00684164
Recruitment Status : Withdrawn (Unable to complete a contract with the Sponsor)
First Posted : May 26, 2008
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Columbia University

Tracking Information
First Submitted Date  ICMJE May 22, 2008
First Posted Date  ICMJE May 26, 2008
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00684164 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
The 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients
Official Title  ICMJE Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyponatremia
Intervention  ICMJE
  • Drug: Conivaptan
    20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days
    Other Name: VAPRISOL
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Conivaptan
  • 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.
    Intervention: Other: D5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 5, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2008)
50
Estimated Study Completion Date  ICMJE June 2010
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00684164
Other Study ID Numbers  ICMJE AAAC6833
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephan A. Mayer, MD, Columbia University Medical Center
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Astellas Pharma Inc
Investigators  ICMJE
Principal Investigator: Stephan A. Mayer, MD Columbia University
PRS Account Columbia University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP