A clinical study in acute head injury patients to study the relation of blood cortisol levels on unstable blood pressure and outcome after head injury
Not Applicable
- Conditions
- Health Condition 1: null- In adult traumatic brain injury to study the relation of blood cortisol levels on unstable hemodynamics and to evaluate outcome after head injury
- Registration Number
- CTRI/2017/09/009816
- Lead Sponsor
- IMHANS intramural research grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Moderate TBI or severe TBI patients requiring vasoactive drugs to maintain adequate mean arterial blood pressure within 2 days of injury and requiring physiologic replacement doses of hydrocortisone.
2)Age 16 to 65 years.
3)Isolated TBI (CT-scan confirmed brain tissue injury without other major extra cranial injuries)
Exclusion Criteria
1)Penetrating head injury.
2)Extra-cranial injury.
3)Preexisting adrenal or pituitary insufficiency, or received glucocorticoids within 3 months of injury.
4)Patients having history of coronary artery disease/ Hypertension.
5)Patients on etomidate, high dose thiopental sodium or propofol
6)Pregnant patients
7)No consent from patientâ??s care taker.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemodynamic steroid responsivenessTimepoint: Patients are considered steroid responsive if hemodynamics improved with in 12 hours of hydrocortisone administration and will be able to taper vasoactive agent, followed by discontinued within 3 days of hydrocortisone administration
- Secondary Outcome Measures
Name Time Method a)Mortality at 14 days and Glasgow Outcome Scale (GOS) at 6 months <br/ ><br>b)Length of ICU stay/Hospital stay <br/ ><br>c)Duration of Mechanical ventilationTimepoint: Mortality at 14 days and Glasgow Outcome Scale (GOS) at 6 months