Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery

NCT04523909 | Recruiting

• 1 other identifier: CMO 2017-3774
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction; Thoracic Aortic Aneurysm

Outcome Measures

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.

  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 baseline

Secondary Outcomes (7)

• Trajectory of the concentration of a panel of inflammatory proteins in plasma

  9 timepoints: Baseline to 72 hours after surgery

• Trajectory of blood-CSF barrier disruption based on CSF/Plasma albumine ratio

  9 timepoints: Baseline to 72 hours after surgery

• Occurence of postoperative delirium

  14-day incidence of delirium

• Trajectory of brain injury markers in CSF

  9 timepoints: Baseline to 72 hours after surgery

• Trajectory of brain injury markers in plasma

  9 timepoints: Baseline to 72 hours after surgery

Study Arms (1)

Thoracic aortic surgery patients

Diagnostic Test: Trajectory of neuroinflammatory proteins in CSF and blood

Interventions

Trajectory of neuroinflammatory proteins in CSF and blood DIAGNOSTIC_TEST

Kinetics of neuroinflammatory markers in CSF and blood

Thoracic aortic surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing thoracic aortic surgery who will therefore receive an external lumbar drain as a standard of care procedure.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Intensive Care Medicine, Radboud university medical center

Nijmegen, 6500HB, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

paired blood and CSF samples

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Aortic Aneurysm, Thoracic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Wilson F. Abdo, MD, PhD

CONTACT

+31243617273; f.abdo@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: August 24, 2020
• Study Start: December 18, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

NL (1)