This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury Clinical Trial
— SANIOfficial title:
Sodium Management in Patients With Acute Neurological Injury
| NCT number | NCT01558843 |
| Other study ID # | 201203034 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 1, 2012 |
| Est. completion date | October 1, 2016 |
| Verified date | April 2019 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This multicenter, observational, study will enroll severe neurologically injured patients both prospectively and retrospectively. The aims are to identify the percent of neurocritical care patients with sodium levels ≤ 135 mEq/L, describe treatment strategies employed, determine the correlation of clinical factors (i.e. GCS, ICP) with serum sodium concentrations in patients prior to sodium altering therapy, and evaluate outcomes through evaluation of length of stay, discharge disposition, and modified Rankin score (mRS).
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | October 1, 2016 |
| Est. primary completion date | October 1, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - age = 18 years of age - admitted to an intensive care unit for more than 48 hours - ICD-9 codes for aneurysmal SAH, TBI, IPH, or intracranial tumor. Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Johns Hopkins hospital | Baltimore | Maryland |
| United States | University of Virginial Health System | Charlottesville | Virginia |
| United States | University of Chicago | Chicago | Illinois |
| United States | UC Health -University Hospital | Cincinnati | Ohio |
| United States | Detroit Receiving Hospital | Detroit | Michigan |
| United States | Spectrum Health | Grand Rapids | Michigan |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | University of Tennessee | Knoxville | Tennessee |
| United States | UK Healthcare | Lexington | Kentucky |
| United States | Jackson Memorial Hospital | Miami | Florida |
| United States | Yale-New Haven Hospital | New Haven | Connecticut |
| United States | Columbia University | New York | New York |
| United States | Virginial Commonwealth University | Richmond | Virginia |
| United States | St Louis University Hospital | Saint Louis | Missouri |
| United States | Washington University | Saint Louis | Missouri |
| United States | Memorial University Medical Center | Savannah | Georgia |
| United States | Via Christi Hospital | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine | Astellas Pharma Inc |
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