Skip to content

Cortisol profiles in the critically ill after traumatic brain injury

Cortisol profiles in the critically ill after traumatic brain injury

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN37782238
Enrollment
30
Registered
2019-09-04
Start date
2019-09-02
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Traumatic brain injury (TBI) - moderate and severe, major trauma without traumatic brain injury Injury, Occupational Diseases, Poisoning

Interventions

The 24-hour tissue cortisol profile will be mapped using subcutaneous microdialysis. This involves a small probe being inserted into the subcutaneous tissue overlying the abdomen, and attachment to a

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the TBI groups: 1. Adults aged at least 18 years of age 2. Intensive Care Unit admission 3. Traumatic brain injury: 3.1. 10 patients with moderate TBI (Glasgow Coma Score 9-12 after resuscitation or prior to intubation) 3.2. 10 patients with severe TBI (Glasgow Coma Score =8 after resuscitation or prior to intubation) Inclusion criteria for the non-TBI group: 1. Adults aged at least 18 years of age 2. Bodily injuries sustained as a result of trauma but without significant head injury 3. Intensive Care Unit admission

Exclusion criteria

Exclusion criteria: Exclusion criteria for the TBI groups: 1. Life or limb-threatening extra-cranial injury (in the opinion of the treating intensivist) 2. Patients with known pre-existing HPA axis disease 3. Untreated thyroid disease 4. Current or prior steroid therapy within the last 3 months 5. Patients less than 18 years of age 6. Patients who are pregnant 7. Prisoners 8. Widespread burns/skin breakdown creating inability to place microdialysis catheter 9. Admission with perceived devastating brain injury for purposes of prognostication or organ donation 10. Refusal of consent or assent 11. More than 48 hours after injury 12. Severe metabolic acidosis (pH <7.20) Exclusion criteria for the non-TBI group: 1. Significant head injury (GCS <13 or abnormal admission brain imaging) 2. Patients with known pre-existing HPA axis disease 3. Untreated thyroid disease 4. Current or prior steroid therapy within the last 3 months 5. Patients less than 18 years of age 6. Patients who are pregnant 7. Prisoners 8. Widespread burns/skin breakdown creating inability to place microdialysis catheter 9. Admission with devastating brain injury for purposes of prognostication or organ donation 10. Refusal of consent or assent 11. More than 48 hours after injury 12. Severe metabolic acidosis (pH <7.20)

Design outcomes

Primary

MeasureTime frame
Tissue cortisol level measured by subcutaneous microdialysis every 20 minutes for 24 hours, generating a 24-hour hormone profile

Secondary

MeasureTime frame
Measured using ICU observation charts, medical notes and ICNARC audit data (collected for every patient routinely during an ICU stay): 1. Acute hospital mortality: inpatient mortality during acute hospital stay 2. Cardiac arrest during inpatient stay 3. Duration of renal replacement therapy in hours (during ICU stay) 4. Duration of mechanical ventilation in hours (during ICU stay) 5. Total number of spikes in intracranial pressure (ICP) during ICU stay and max level recorded 6. Amount of time in hours spent with ICP greater than 20 mmHg 7. Maximum therapy intensity level whilst on ICU (relates to degree of therapy for raised ICP) 8. Number of days of ICP targeted therapy whilst on ICU 9. Total dose and duration (in hours) or inotrope and vasopressor therapy whilst on ICU 10. Length of ICU stay in days 11. Length of hospital stay in days 12. Level of care at ICU discharge using ICNARC (Intensive Care National Audit and Research Centre) scale 13. Expected dependency post-acute hospital discharge using ICNARC scale 14. Residence post-discharge from acute hospital using ICNARC data

Countries

United Kingdom

Contacts

Public ContactBen Gibbison
ben.gibbison@bristol.ac.uk+44 (0)7932059594

Outcome results

None listed

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