Examining the effects of trauma and critical illness on brain function
The Immune Response of the Human Brain in Survivors of Critical Illness
This study looks at how trauma and serious illness affect brain function in ICU patients over time to see what might cause memory and thinking problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05245253 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how trauma and critical illness impact cognitive function and the brain's health. It involves a prospective analysis of twenty trauma patients treated in an intensive care unit, utilizing consecutive PET imaging, EEG, biomarkers, and cognitive testing at three different time points: within three weeks of trauma, after three months, and after twelve months. The study seeks to uncover the underlying mechanisms of cognitive impairment in ICU survivors, particularly focusing on the effects of inflammation and peripheral injury on brain health.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 20-60 who have experienced significant trauma with an Injury Severity Score of 15 or higher.
Not a fit: Patients with pre-existing neuropsychiatric disorders or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive dysfunction in patients recovering from critical illness.
How similar studies have performed: While cognitive impairment following critical illness is well-documented, this specific approach using PET imaging and comprehensive cognitive testing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 20-60 years of age. 2. Trauma with an ISS score of ≥15 3. Informed consent Exclusion Criteria: 1. Patient´s refusal to participate in the trial 2. Any traumatic brain or spinal injury prior to admission 3. Disabling neuropsychiatric disorder (dementia-diagnosis, Mb Alzheimer, Mb Parkinson, schizophrenia or severe mental depression prior to ICU admission) 4. Any preadmission history of stroke with neurological sequelae 5. Co-morbidities prior to ICU admission such as severe cardiac, hepatic, hematological or renal impairment 6. Terminal phase of chronic disease or malignancy 7. High-dose steroid treatment before ICU admission or during ICU care 8. Presumed uncooperativeness or legal incapacity
Where this trial is running
Stockholm
- Karolinska University Hospital, Perioperative Medicine and Intensive Care — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Jessica Kåhlin, MD, PhD
- Email: jessica.kahlin@sll.se
- Phone: +46707295456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.