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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 30, 2008 | ||||
| Last Updated Date | July 7, 2009 | ||||
| Start Date ICMJE | August 2008 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in serum sodium at 6, 12, 18, 24, 26 and 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00727090 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
NIH Stroke Scale and Glasgow Coma Scale at 24 and 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients | ||||
| Official Title ICMJE | Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients | ||||
| 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). |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hyponatremia | ||||
| Intervention ICMJE | Drug: Conivaptan | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00727090 | ||||
| Responsible Party | Andrew Naidech, Northwestern University | ||||
| Study ID Numbers ICMJE | 1507-10 | ||||
| Study Sponsor ICMJE | Northwestern University | ||||
| Collaborators ICMJE | Astellas Pharma US, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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