Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

Delirium Clinical Trial

Official title:

Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007755
• Other study ID #: TJMZK202301
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Huazhong University of Science and Technology
• Contact: Hua Zheng, Dr.
• Phone: 0086-27-83663173
• Email: hzheng[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	the level of Aß in serum of postoperative delirium and un-delirium patients	the level of Aß in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor	Perioperative data
Secondary	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
Secondary	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