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

NCT03706989 | Completed

• 1 other identifier: 2018/20SEP/350
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Keywords

EEG; Apolipoprotein genotyping; Perioperative brain injury

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium (POD)

  Development of POD after cardiac surgery (using CAM, CAM-ICU, flow chart review)

  from postoperative awakening in ICU until discharge from the hospital (assessed up to 7 days postoperatively)

Secondary Outcomes (2)

• Length of stay

  Up to one month

• Postoperative cognitive dysfunction

  6 months after surgery

Study Arms (1)

EEG for cardiac surgery patients

EXPERIMENTAL

Patients who undergo elective cardiac surgery with cardiopulmonary bypass, from 18 to \>75 years old.

Procedure: EEG; Genetic: Apolipoprotein genotype; Biological: Serum NfL measurements; Other: Preoperative neurocognitive evaluation

Interventions

EEG PROCEDURE

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

EEG for cardiac surgery patients

Apolipoprotein genotype GENETIC

APOE genotyping will be performed for each patient

EEG for cardiac surgery patients

Serum NfL measurements BIOLOGICAL

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

EEG for cardiac surgery patients

Preoperative neurocognitive evaluation OTHER

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

EEG for cardiac surgery patients

Eligibility Criteria

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

You may qualify if:

• patients who undergo elective cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• non-French speaking patients
• hypothermic cardiopulmonary bypass
• second (or more) cardiac intervention
• endocarditis
• preoperative delirium
• psychiatric disorders
• uncompleted preoperative neurocognitive tests
• preoperative anti-epileptic treatment
• chronic ethylism
• terminal kidney insufficiency with dialyses

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (8)

• Giattino CM, Gardner JE, Sbahi FM, Roberts KC, Cooter M, Moretti E, Browndyke JN, Mathew JP, Woldorff MG, Berger M; MADCO-PC Investigators. Intraoperative Frontal Alpha-Band Power Correlates with Preoperative Neurocognitive Function in Older Adults. Front Syst Neurosci. 2017 May 8;11:24. doi: 10.3389/fnsys.2017.00024. eCollection 2017.

  PMID: 28533746 RESULT

• Brown EN, Purdon PL. The aging brain and anesthesia. Curr Opin Anaesthesiol. 2013 Aug;26(4):414-9. doi: 10.1097/ACO.0b013e328362d183.

  PMID: 23820102 RESULT

• de Waal H, Stam CJ, de Haan W, van Straaten EC, Blankenstein MA, Scheltens P, van der Flier WM. Alzheimer's disease patients not carrying the apolipoprotein E epsilon4 allele show more severe slowing of oscillatory brain activity. Neurobiol Aging. 2013 Sep;34(9):2158-63. doi: 10.1016/j.neurobiolaging.2013.03.007. Epub 2013 Apr 12.

  PMID: 23587637 RESULT

• Vasunilashorn S, Ngo L, Kosar CM, Fong TG, Jones RN, Inouye SK, Marcantonio ER. Does Apolipoprotein E Genotype Increase Risk of Postoperative Delirium? Am J Geriatr Psychiatry. 2015 Oct;23(10):1029-1037. doi: 10.1016/j.jagp.2014.12.192. Epub 2015 May 21.

  PMID: 26238230 RESULT

• Evered L, Silbert B, Scott DA, Zetterberg H, Blennow K. Association of Changes in Plasma Neurofilament Light and Tau Levels With Anesthesia and Surgery: Results From the CAPACITY and ARCADIAN Studies. JAMA Neurol. 2018 May 1;75(5):542-547. doi: 10.1001/jamaneurol.2017.4913.

  PMID: 29459944 RESULT

• Halaas NB, Blennow K, Idland AV, Wyller TB, Raeder J, Frihagen F, Staff AC, Zetterberg H, Watne LO. Neurofilament Light in Serum and Cerebrospinal Fluid of Hip Fracture Patients with Delirium. Dement Geriatr Cogn Disord. 2018;46(5-6):346-357. doi: 10.1159/000494754. Epub 2018 Dec 6.

  PMID: 30522125 RESULT

• Lagios MH, Bidoul T, Momeni M, Khalifa C. Is There a Better Timing for Frontal Electroencephalogram Alpha Band Power Quantification to Predict Delirium After Cardiac Surgery? Anesth Analg. 2025 Sep 1;141(3):671-673. doi: 10.1213/ANE.0000000000007492. Epub 2025 Mar 25. No abstract available.

  PMID: 40131805 DERIVED

• Khalifa C, Lenoir C, Robert A, Watremez C, Kahn D, Mastrobuoni S, Aphram G, Ivanoiu A, Bonhomme V, Mouraux A, Momeni M. Intra-operative electroencephalogram frontal alpha-band spectral analysis and postoperative delirium in cardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2023 Oct 1;40(10):777-787. doi: 10.1097/EJA.0000000000001895. Epub 2023 Aug 8.

  PMID: 37551153 DERIVED

MeSH Terms

Conditions

Emergence Delirium

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

Study Officials

• Mona Momeni, MD, PhD

  Cliniques universitaires Saint-Luc, UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Only one group of cardiac patients divided in sub-groups according to their age.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: May 15, 2019
• Primary Completion: December 15, 2021
• Study Completion: June 15, 2022
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)