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Sodium Management in Acute Neurological Injury (SANI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Washington University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Theresa Human-Murphy, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01558843
First received: March 17, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose
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).

Condition
The Focus of the Study is to Understand the Current Practice of Sodium Management in Patients With Acute Neurological Injury.

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Sodium Management in Patients With Acute Neurological Injury

Further study details as provided by Washington University School of Medicine:

Estimated Enrollment: 400
Study Start Date: February 2012
Groups/Cohorts
traumatic brain injury
aneurysmal subarachnoid hemorrhage
intracerebral hematoma
brain tumor

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients identified for enrollment will be age ≥ 18 years of age, admitted to an intensive care unit for more than 48 hours with ICD-9 codes for aneurysmal SAH, TBI, IPH, or intracranial tumor.
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558843

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06504
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60612
United States, Kansas
Via Christi Hospital
Wichita, Kansas, United States, 677214
United States, Kentucky
UK Healthcare
Lexington, Kentucky, United States, 40536
United States, Maryland
The Johns Hopkins hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Missouri
St Louis University Hospital
St Louis, Missouri, United States, 63110
Washington University
St Louis, Missouri, United States, 63110
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Ohio
UC Health -University Hospital
Cincinnati, Ohio, United States, 45219
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37920
United States, Virginia
University of Virginial Health System
Charlottesville, Virginia, United States, 22908
Virginial Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Washington University School of Medicine
Astellas Pharma Inc
Investigators
Principal Investigator: Gretchen Brophy, Pharm.D VCU
Principal Investigator: Theresa Murphy-Human, Pharm.D. Washington University School of Medicine
  More Information

Responsible Party: Theresa Human-Murphy, Pharm.D., BCPS, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01558843     History of Changes
Other Study ID Numbers: 201203034 
Study First Received: March 17, 2012
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Sodium Management
Neurointensive Care
Hyponatremia

Additional relevant MeSH terms:
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases

ClinicalTrials.gov processed this record on December 08, 2016