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

NCT ID: NCT04523909

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-18

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Major (cardiovascular) surgery is frequently associated with cerebral dysfunction postoperatively. Major surgical procedures account for substantial systemic inflammatory activation. Interestingly, animal models have shown that surgery rather than anaesthetics trigger a neurocognitive decline. An increase of pro-inflammatory cytokines and activation of immune cells mediate this post operative cognitive decline. There is growing support that systemic inflammation can activate the innate immune system of the brain leading to inflammation in the brain ('neuroinflammation'). This neuroinflammation is suggested to play a pivotal role in postoperative delirium and postoperative cognitive decline due to surgery-related systemic inflammation. However little evidence is available on the extend of the neuroinflammation and which biochemical pathways are dysregulated in the brain after surgery.

Thoracic aortic surgery offers the unique opportunity to study the trajectory of protein expression in CSF prior to and after surgery in a non-invasive matter. It is standard of care that an external lumbar drain (ELD) is placed the day prior to surgery and this ELD will remain in place during three postoperative days.

To advance the understanding of the impact of major surgery to the brain, the investigators wish to study the trajectory of protein expression prior to and after thoracic aortic surgery.

Conditions

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Postoperative Delirium Postoperative Cognitive Dysfunction Thoracic Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thoracic aortic surgery patients

Trajectory of neuroinflammatory proteins in CSF and blood

Intervention Type DIAGNOSTIC_TEST

Kinetics of neuroinflammatory markers in CSF and blood

Interventions

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Trajectory of neuroinflammatory proteins in CSF and blood

Kinetics of neuroinflammatory markers in CSF and blood

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Wilson F. Abdo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Intensive Care Medicine, Radboud university medical center

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Wilson F. Abdo, MD, PhD

Role: CONTACT

+31243617273

Facility Contacts

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Wilson F. Abdo, MD, PhD

Role: primary

0243617273

Other Identifiers

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CMO 2017-3774

Identifier Type: -

Identifier Source: org_study_id

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