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CompletedNCT01558843SANIUpdated May 1, 2019

Sodium Management in Acute Neurological Injury

An observational study in This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury, sponsored by Washington University School of Medicine. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-01.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

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

Keywords

  • Sodium Management
  • Neurointensive Care
  • Hyponatremia
03

In context

Trauma, Nervous System

85 studies on the registry are indexed under Trauma, Nervous System; 26 are open to participants now.

This study's enrollment of 400 is above the median of 120 across 21 observational studies indexed under Trauma, Nervous System.

Browse Trauma, Nervous System studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (actual)

Groups and cohorts

  • traumatic brain injury
  • aneurysmal subarachnoid hemorrhage
  • intracerebral hematoma
  • brain tumor
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Study locations

17 sites
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Yale-New Haven Hospital
    New Haven, Connecticut 06504, United States
  • Jackson Memorial Hospital
    Miami, Florida 33136, United States
  • Memorial University Medical Center
    Savannah, Georgia 31404, United States
  • University of Chicago
    Chicago, Illinois 60612, United States
  • Via Christi Hospital
    Wichita, Kansas 677214, United States
  • UK Healthcare
    Lexington, Kentucky 40536, United States
  • The Johns Hopkins hospital
    Baltimore, Maryland 21287, United States
  • Detroit Receiving Hospital
    Detroit, Michigan 48201, United States
  • Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • St Louis University Hospital
    Saint Louis, Missouri 63110, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Columbia University
    New York, New York 10032, United States
  • UC Health -University Hospital
    Cincinnati, Ohio 45219, United States
  • University of Tennessee
    Knoxville, Tennessee 37920, United States
  • University of Virginial Health System
    Charlottesville, Virginia 22908, United States
  • Virginial Commonwealth University
    Richmond, Virginia 23298, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01558843
Lead sponsor
Washington University School of Medicine
Collaborators
Astellas Pharma Inc
Responsible party
Theresa Human-Murphy (Pharm.D., BCPS, Washington University School of Medicine) — Principal investigator
First posted
Mar 20, 2012
Start date
Feb 1, 2012
Primary completion
Oct 1, 2014
Completion
Oct 1, 2016
Last update
May 1, 2019

Study contacts

Gretchen Brophy, Pharm.D
principal investigator · VCU
Theresa Murphy-Human, Pharm.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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