Sodium Management in Acute Neurological Injury

NCT ID: NCT01558843

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-01

Study Completion Date

2016-10-01

Brief Summary

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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).

Detailed Description

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Conditions

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This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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traumatic brain injury

No interventions assigned to this group

aneurysmal subarachnoid hemorrhage

No interventions assigned to this group

intracerebral hematoma

No interventions assigned to this group

brain tumor

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Theresa Human-Murphy

Pharm.D., BCPS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gretchen Brophy, Pharm.D

Role: PRINCIPAL_INVESTIGATOR

VCU

Theresa Murphy-Human, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Memorial University Medical Center

Savannah, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Via Christi Hospital

Wichita, Kansas, United States

Site Status

UK Healthcare

Lexington, Kentucky, United States

Site Status

The Johns Hopkins hospital

Baltimore, Maryland, United States

Site Status

Detroit Receiving Hospital

Detroit, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

St Louis University Hospital

St Louis, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Columbia University

New York, New York, United States

Site Status

UC Health -University Hospital

Cincinnati, Ohio, United States

Site Status

University of Tennessee

Knoxville, Tennessee, United States

Site Status

University of Virginial Health System

Charlottesville, Virginia, United States

Site Status

Virginial Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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201203034

Identifier Type: -

Identifier Source: org_study_id

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