CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 387 enrolled
Drug / intervention
Apolipoprotein genotype +3 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03706989
NCT03706989N/ACompleted

Predicting Postoperative Delirium Using Intraoperative EEG Alpha Wave Analysis, APOE Genotyping and NfL as a Biomarker of Cerebral Injury

Cliniques universitaires Saint-Luc- Université Catholique de Louvain·interventional·Posted Oct 16, 2018·Updated May 17, 2024

In Brief

A clinical study evaluating EEG, Apolipoprotein genotype, and 2 other interventions for Postoperative Delirium. Completed, enrolled 387 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 16, 2018
Enrollment StartMay 15, 2019
Primary CompletionDec 15, 2021
Study CompletionJun 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.7 years ago

Interventions

EEGprocedure

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

Apolipoprotein genotypegenetic

APOE genotyping will be performed for each patient

Serum NfL measurementsbiological

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

Preoperative neurocognitive evaluationother

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