Clinical trial NCT01558843: Sodium Management in Acute Neurological Injury
Official title: Sodium Management in Patients With Acute Neurological Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury
Keywords: Sodium Management
Neurointensive Care
Hyponatremia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2012-03-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).


Eligibility 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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Savannah
country: United States
facility: Memorial University Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Wichita
country: United States
facility: Via Christi Hospital
state: Kansas
city: Lexington
country: United States
facility: UK Healthcare
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins hospital
state: Maryland
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Saint Louis
country: United States
facility: St Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: UC Health -University Hospital
state: Ohio
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginial Health System
state: Virginia
city: Richmond
country: United States
facility: Virginial Commonwealth University
state: Virginia
Study officials:
affiliation: VCU
name: Gretchen Brophy, Pharm.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Theresa Murphy-Human, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: