Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

NCT06007755 | Recruiting

• 1 other identifier: TJMZK202301
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium

Keywords

delirium; biomarker; cardiovascular surgery; H3K18la; exosome; phospho-tau; Aβ

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the level of H3K18 in serum monocytes of postoperative delirium and un-delirium patients

  Perioperative data

• the level of Aβ in serum of postoperative delirium and un-delirium patients

  Perioperative data

• the level of tau in serum of postoperative delirium and un-delirium patients

  Perioperative data

• the level of exosomes in serum of postoperative delirium and un-delirium patients

  Perioperative data

Study Arms (2)

Delirium is determined by 3D-CAM score

No delirium is determined by 3D-CAM score

Eligibility Criteria

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

Study Population

Patients aged over 18 years undergoing cardiovascular surgery

You may qualify if:

• patients who receive cardiovascular surgery
• Patients participated voluntarily and signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Hua Zheng, Dr.

CONTACT

0086-27-83663173; hzheng@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (1)