Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients

Hyponatremia Clinical Trial

Official title:

Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00684164
• Other study ID #: AAAC6833
• Status: Withdrawn
• Phase: Phase 3
• First received: May 22, 2008
• Last updated: March 5, 2015
• Start date: May 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• Conivaptan
20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in serum sodium over the duration of treatment between the two treatment arms.		From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment	No
Secondary	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		From the initiation of treatment to the end of treatment, up to 4 days	Yes