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Sodium Management in Acute Neurological Injury (SANI)

This study is currently recruiting participants.
Verified March 2012 by Washington University School of Medicine
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
History of Changes
  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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558843

Contacts
Contact: Theresa Murphy-Human, Pharm.D.,BCPS 314-747-8799 txm5120@bjc.org

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Norah Liang, Pharm.D.         nliang@harthosp.org    
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06504
Contact: Amber Castle, Pharm.D.         amber.castle@ynhh.org    
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Christopher Morrison, Pharm.D.         christopher.morris@jhsmiami.org    
United States, Georgia
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: David Deen, Pharm.D.         deenda1@memorialhealth.com    
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Eljm Tesoro, Pharm.D.         etesoro@uic.edu    
United States, Kansas
Via Christi Hospital Recruiting
Wichita, Kansas, United States, 677214
Contact: Scott Taylor, Pharm.D.         scott.taylor@viachristi.org    
United States, Kentucky
UK Healthcare Recruiting
Lexington, Kentucky, United States, 40536
Contact: Aaron Cook, Pharm.D.         amcook0@email.uky.edu    
United States, Maryland
The Johns Hopkins hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Haley E Goodwin, Pharm.D.         hgoodwi3@jhmi.edu    
United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Dennis Parker, Pharm.D.         ah2262@wayne.edu    
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Karen McAllen, Pharm.D.         karen.mcallen@spectrumhealth.org    
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Theresa Murphy-Human, Pharm.D.     314-747-8799     txm5120@bjc.org    
St Louis University Hospital Recruiting
St Louis, Missouri, United States, 63110
Contact: Brian Anger, Pharm.D.         brian.anger@tenethealth.com    
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Christine Lesch, Pharm.D.         cal9005@nyp.org    
United States, Ohio
UC Health -University Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Kiranpal Sangha, Pharm.D.         kiranpal.sangha@uchealh.com    
United States, Tennessee
University of Tennessee Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Shaun Rowe, Pharm.D.         arowe@uthsc.edu    
United States, Virginia
University of Virginial Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kathleen Bledsoe, Pharm.D.         kv9k@hscmail.mcc.virginia.edu    
Contact: Bart Nathan, MD         brn3a@virginia.edu    
Virginial Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Gretchen Brophy, Pharm.D.     804-828-1201     gbrophy@vcu.edu    
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

No publications provided

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:
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013