Predicting Postoperative Delirium Using EEG, Genetics and Neurobiomarkers of Cerebral Injury

NCT03706989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2024-05-17

No results posted yet for this study

Summary

The overall goal of this research project is to elucidate underlying pathophysiological mechanisms of postoperative delirium (POD) and to specifically validate perioperative predictive factors that will help in indentifying patients at higher risk of developing POD.

1. The main objective is to evaluate whether intraoperative frontal alpha power in unprocessed electroencephalogram (EEG), under general anesthesia, is associated with the occurrence of POD, and whether specific patterns worrelate with the patient's preoperative cognitive status.
2. As apolipoprotein E (APOE) polymorphism has been shown to be a risk factor of POD, we will specifically analyze whether patients who are APOEe4 carriers present different intraoperative EEG patterns in terms of anteriorization of the alpha frequency band under general anesthesia, and investigate whether the APOEe4 carriers are at higher risk of POD.
3. In this research project, we will also analyze the perioperative kinetics of serum neurofilament light chain protein (NfL), a biomarker of neuronal injury. We will specifically analyze whether preoperative, as well as postoperative serum NfL levels are higher in patients presenting POD, compared to those who do not experience POD. This will allow studying whether neuronal damage may be involved in the pathogenesis of POD.

Conditions

  • Postoperative Delirium

Interventions

PROCEDURE

EEG

EEG samples will be recorded before and during the cardiac surgery in order to perform spectral and coherence analyses

GENETIC

Apolipoprotein genotype

APOE genotyping will be performed for each patient

BIOLOGICAL

Serum NfL measurements

5 perioperative blood samples will be taken to measure the evolution of NfL in the serum (before and until postoperative day 5)

OTHER

Preoperative neurocognitive evaluation

Each patient will benefit from a complete neurocognitive evaluation before surgery (battery of validated cognitive tests)

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Mona Momeni, MD, PhD · Cliniques universitaires Saint-Luc, UCL

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-12-15
Completion
2022-06-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03706989 on ClinicalTrials.gov