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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 Theresa Human-Murphy, Washington University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558843
First Posted: March 20, 2012
Last Update Posted: March 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Theresa Human-Murphy, Washington University School of Medicine
  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 Theresa Human-Murphy, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
St Louis University Hospital Recruiting
St Louis, Missouri, United States, 63110
Contact: Brian Anger, Pharm.D.       brian.anger@tenethealth.com   
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Theresa Murphy-Human, Pharm.D.    314-747-8799    txm5120@bjc.org   
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

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
First Submitted: March 17, 2012
First Posted: March 20, 2012
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Theresa Human-Murphy, Washington University School of Medicine:
Sodium Management
Neurointensive Care
Hyponatremia

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


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