Cortisol profiles in the critically ill after traumatic brain injury

Not Applicable

Suspended

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

• Registration Number: ISRCTN37782238
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-04
• Last Update Posted: 17 August 2020
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 30

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 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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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