Sodium Management in Acute Neurological Injury (SANI)

April 29, 2019 updated by: Theresa Human-Murphy, Washington University School of Medicine

Sodium Management in Patients With Acute Neurological Injury

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
traumatic brain injury
aneurysmal subarachnoid hemorrhage
intracerebral hematoma
brain tumor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Gretchen Brophy, Pharm.D, VCU
  • Principal Investigator: Theresa Murphy-Human, Pharm.D., Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 17, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201203034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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