Status:
WITHDRAWN
Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Hyponatremia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00684164
Start Date
May 1 2008
End Date
June 1 2010
Last Update
March 6 2015
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032