Sodium Imbalance in Traumatic Brain InjuryNCT02940834
Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre
An observational study of Sodium Imbalance in Traumatic Brain Injury, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Observational study about prevalence, predictors of sodium imbalance and prognostic significance. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Sodium Imbalance in Traumatic Brain Injury
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult and paediatric patients with isolated traumatic brain injury admitted in ICU in PGIMER
Who may be able to join
- adult and paediatric patients with isolated head injury
Who cannot join
- age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
DR NIDHI PANDA, MD ANAESTHESIA, 7087009525 ext. +91, nidhibp@gmail.com
About this study
Official title: Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre
Observational study about prevalence, predictors of sodium imbalance and prognostic significance.
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 |
|---|---|---|
| patients with sodium imbalance | Not described | |
| patients without sodium imbalance | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports
Measured: first 10 days after admission in icu or discharge whichever is earlier
Secondary outcomes (2)
predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data
Measured: first 10 days after admission in icu or discharge whichever is earlier
relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically
Measured: 1st and 3rd month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium Imbalance in Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR GANESH ADAIKKALAVAN M, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940834
- Sponsor's protocol ID
- Na TBI
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre
- ClinicalTrials.gov ID
- NCT02940834
- Acronym / sponsor ID
- Na TBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 21 Oct 2016 (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.
Observational study about prevalence, predictors of sodium imbalance and prognostic significance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with sodium imbalance | – | – |
| patients without sodium imbalance | – | – |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult and paediatric patients with isolated traumatic brain injury admitted in ICU in PGIMER
Key inclusion criteria (1 listed)
- adult and paediatric patients with isolated head injury
Key exclusion criteria (1 listed)
- age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma
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
correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports
Time frame: first 10 days after admission in icu or discharge whichever is earlier
2 secondary outcomes
predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data
Time frame: first 10 days after admission in icu or discharge whichever is earlier
relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically
Time frame: 1st and 3rd month after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium Imbalance in Traumatic Brain Injury, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR NIDHI PANDA, MD ANAESTHESIA (7087009525 ext. +91, nidhibp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports (time frame: first 10 days after admission in icu or discharge whichever is earlier). It is what the study was designed to measure, not a finding.
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 21 Oct 2016.