Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre

Sodium Imbalance in Traumatic Brain Injury Clinical Trial

Official title:

Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940834
• Other study ID #: Na TBI
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 20, 2016
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: DR NIDHI PANDA, MD ANAESTHESIA
• Phone: 7087009525
• Email: nidhibp[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Observational

Clinical Trial Summary

Observational study about prevalence, predictors of sodium imbalance and prognostic significance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• adult and paediatric patients with isolated head injury

Exclusion Criteria:

• age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Sodium Imbalance in Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports		first 10 days after admission in icu or discharge whichever is earlier	No
Secondary	predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data		first 10 days after admission in icu or discharge whichever is earlier	No
Secondary	relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically		1st and 3rd month after discharge	No