NCT04523909 Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery
| NCT ID | NCT04523909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Postoperative Delirium |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-12-18 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2017-12-18 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Observational prospective pilot study to analyze the trajectory of neuroinflammatory protein expression in cerebrospinal fluid (CSF) in relation to systemic compartment in patients undergoing thoracic aortic surgery. The aim of this study is to identify and unravel the biochemical (neuroinflammatory) pathways involved in postoperative delirium. Patient undergoing thoracic aortic surgery will have an external lumbar drain (ELD) in situ on the day before surgery. This ELD remains in place during and three days after surgery to reduce the risk on periprocedural spinal cord ischemia. Paired measurements of CSF and blood will be analyzed.
Eligibility Criteria
Inclusion Criteria: * Competent patients ≥ 18 years * Patients who will undergo thoracic aortic surgery and will therefore receive an external lumbar drain as a standard of care procedure. Exclusion Criteria: * Patients with meningitis/encephalitis/brain abscess within the last 6 months * Patients with other neurological conditions: brain injury (acute stroke, brain trauma or cerebral haemorrhage) within the last 3 months, known brain tumours, neurodegenerative disease or known pre-existing cognitive impairment (to a degree that would be compatible with mild cognitive impairment or more). * Brain or spinal surgery within the last 3 months * Active infection \<2 weeks before surgery * Patients who object against storage of their body material for scientific reasons
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04523909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04523909 currently recruiting?
Yes, NCT04523909 is actively recruiting participants. Contact the research team at f.abdo@radboudumc.nl for enrollment information.
Where is the NCT04523909 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT04523909 clinical trial?
NCT04523909 is sponsored by Radboud University Medical Center. The trial plans to enroll 100 participants.