Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

The incidence of postoperative delirium in patients after cardiovascular surgery is very high, which seriously affects the short-term and long-term prognosis of patients, but its mechanism is not clear. Recent studies have found that lactic acid participates in the process of sepsis by inducing histone lactatation in macrophages. histone H3 lysine 18 lactylation (H3K18la) is significantly associated with the severity of disease and inflammatory response. Inflammation plays an important role in postoperative delirium. We therefore hypothesized that macrophage H3K18la also plays a role in postoperative delirium. At the same time, the latest literature shows that the early markers of Alzheimer's disease (AD), such as Aβ, exosomes and phosphorylated tau, etc. [5], can also be detected in the serum of AD patients. Given the obvious correlation between Alzheimer's disease and postoperative delirium [6], we hypothesized that serum biomarkers of AD could also be used as serum biomarkers for postoperative delirium.

The objectives of this study were to investigate the correlation between H3K18 in serum monocytes and postoperative delirium and its severity in patients undergoing cardiovascular surgery. Meanwhile, we also detect the serum levels of biomarkers of AD, such as Aβ, tau and exosomes etc., in patients undergoing major cardiac surgery. We aim to find the serum biomarkers of delirium after major cardiac surgery, so as to provide a more convenient diagnostic basis for the prevention of postoperative delirium.

Study Overview

• Status: Recruiting
• Conditions: Delirium

• Study Type: Observational
• Enrollment (Estimated): 113

Contacts and Locations

• Study Contact: Name: Hua Zheng, Dr.; Phone Number: 0086-27-83663173; Email: hzheng@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Hua Zheng, Dr; Phone Number: +86 18672750530; Email: hzheng@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged over 18 years undergoing cardiovascular surgery

Description

Inclusion Criteria:

patients who receive cardiovascular surgery

• Patients participated voluntarily and signed informed consent

Exclusion Criteria:

• past medical history of neurological and psychiatric diseases; severe visual or hearing impairment;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Delirium is determined by 3D-CAM score
No delirium is determined by 3D-CAM score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	The incidence of postoperative delirium was determined according to the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) diagnostic algorithm. The algorithm consists of four clinical criteria: (1) acute onset and fluctuating course, (2) inattention, and either, (3) disorganized thinking, or(4) altered level of consciousness. To define a patient as having delirium, both the first and the second criteria have to be present, as well as either the third or the fourth criteria.	After surgery through to postoperative day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the level of H3K18 in serum monocytes of postoperative delirium and un-delirium patients	Lactylation levels of all proteins and H3K18 from peripheral blood mononuclear (PBMC) were determined by western blotting and serum levels of inflammatory cytokines by flow cytometry.	Perioperative data
the level of Aβ in serum of postoperative delirium and un-delirium patients	the level of Aβ in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor	Perioperative data
the level of tau in serum of postoperative delirium and un-delirium patients	the level of tau in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor	Perioperative data
the level of exosomes in serum of postoperative delirium and un-delirium patients	the level of exosomes in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor	Perioperative data

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: delirium; biomarker; cardiovascular surgery; exosome; Aβ; phospho-tau; H3K18la
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: TJMZK202301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No