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Trial record 50 of 316 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT02940834
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
DR GANESH ADAIKKALAVAN M, Postgraduate Institute of Medical Education and Research

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

Condition or disease
Sodium Imbalance in Traumatic Brain Injury

Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre
Study Start Date : December 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
patients with sodium imbalance
patients without sodium imbalance



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult and paediatric patients with isolated traumatic brain injury admitted in ICU in PGIMER
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940834


Contacts
Contact: DR NIDHI PANDA, MD ANAESTHESIA 7087009525 ext +91 nidhibp@gmail.com

Locations
India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: DR NIDHI PANDA, MD ANAESTHESIA    7087009525 ext +91    nidhibp@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Responsible Party: DR GANESH ADAIKKALAVAN M, DR, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02940834     History of Changes
Other Study ID Numbers: Na TBI
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System