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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

Role of circulating cortisol levels on hemodynamic instability and outcome after acute traumatic brain injury

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009816
Enrollment
50
Registered
2017-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

None listed

Sponsors

NIMHANS intramural research grant
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
a) Mortality at 14 days and Glasgow Outcome Scale (GOS) at 6 months b) Length of ICU stay/Hospital stay c) Duration of Mechanical ventilationTimepoint: Mortality at 14 days and Glasgow Outcome Scale (GOS) at 6 months—

Countries

India

Contacts

Public ContactDrGopalakrishna K N

National Institute of Mental Health and Neurosciences (NIMHANS)

gops868@gmail.com9916469626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026