This Study is to Understand the Current Practice of Sodium Management in Acute Neurological InjurySANINCT01558843
Sodium Management in Acute Neurological Injury
An observational study of This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury, run by Washington University School of Medicine at 17 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury
- How many people
- 400 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Feb 2012to 1 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The Johns Hopkins hospital
Baltimore, Maryland, 21287
University of Virginial Health System
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60612
UC Health -University Hospital
Cincinnati, Ohio, 45219
Detroit Receiving Hospital
Detroit, Michigan, 48201
Spectrum Health
Grand Rapids, Michigan, 49503
Hartford Hospital
Hartford, Connecticut, 06102
University of Tennessee
Knoxville, Tennessee, 37920
UK Healthcare
Lexington, Kentucky, 40536
Jackson Memorial Hospital
Miami, Florida, 33136
Yale-New Haven Hospital
New Haven, Connecticut, 06504
Columbia University
New York, New York, 10032
Virginial Commonwealth University
Richmond, Virginia, 23298
Memorial University Medical Center
Savannah, Georgia, 31404
St Louis University Hospital
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
Via Christi Hospital
Wichita, Kansas, 677214
About this study
Official title: 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).
- Conditions
- This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury
- Keywords
- Sodium Management, Neurointensive Care, Hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| traumatic brain injury | Not described | |
| aneurysmal subarachnoid hemorrhage | Not described | |
| intracerebral hematoma | Not described | |
| brain tumor | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study start1 Feb 2012
- Primary completion1 Oct 2014
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study is to Understand the Current Practice of Sodium Management in Acute Neurological InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Theresa Human-Murphy, Washington University School of Medicine
- Investigators
- Gretchen Brophy, Pharm.D, Principal investigator, VCUTheresa Murphy-Human, Pharm.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558843
- Sponsor's protocol ID
- 201203034
- Acronym
- SANI
- Status last verified
- Apr 2019
- First submitted
- 17 Mar 2012
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Management in Patients With Acute Neurological Injury
- ClinicalTrials.gov ID
- NCT01558843
- Acronym / sponsor ID
- SANI / 201203034
- Conditions
- This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury
- Keywords
- Sodium Management, Neurointensive Care, Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| traumatic brain injury | – | – |
| aneurysmal subarachnoid hemorrhage | – | – |
| intracerebral hematoma | – | – |
| brain tumor | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen Brophy, Pharm.D principal investigator
VCU
Theresa Murphy-Human, Pharm.D. principal investigator
Washington University School of Medicine
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury, run by Washington University School of Medicine at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.