Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Adult patients undergoing thoracic aortic surgery who will therefore receive an external lumbar drain as a standard of care procedure.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Trajectory of neuroinflammatory proteins in CSF and blood
Diagnostic testKinetics of neuroinflammatory markers in CSF and blood
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Thoracic aortic surgery patients1 intervention
Trial outcomes
Primary outcomes
1
Trajectory of the concentration of a panel of inflammatory proteins in CSF
Changes in CSF cytokine concentrations will be determined (including IL6, IL8, IL10, MCP-1, IL1RA and CX3CL1) between timepoints described below.
Time frame
9 timepoints: Baseline (immediately before surgery); Start extracorporeal circulation; Stop extracorporeal circulation (ECC); 2 hours (h) after stop ECC; 4h after stop ECC; 6h after stop ECC; 24h after baseline; 48h after baseline; 72h after baselineSecondary outcomes
1
Trajectory of the concentration of a panel of inflammatory proteins in plasma
Changes in plasma cytokine concentrations will be determined (including IL6, IL8, IL10, MCP-1, IL1RA and CX3CL1) between timepoints described below.
Time frame
9 timepoints: Baseline to 72 hours after surgery2
Trajectory of blood-CSF barrier disruption based on CSF/Plasma albumine ratio
CSF/Plasma albumine ratios will be measured for all timepoints where paired CSF/plasma samples are present
Time frame
9 timepoints: Baseline to 72 hours after surgery3
Occurence of postoperative delirium
Yes or No
Time frame
14-day incidence of delirium4
Trajectory of brain injury markers in CSF
Changes in brain injury markers will be determined (including NFL, S100B, GFAP, UCHL1, NSE)
Time frame
9 timepoints: Baseline to 72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov