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RecruitingNCT06007755Updated Apr 3, 2026

Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

An observational study in Delirium, sponsored by Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Huazhong University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
113
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Delirium

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Keywords

  • delirium
  • biomarker
  • cardiovascular surgery
  • H3K18la
  • exosome
  • phospho-tau
  • Aβ
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients aged over 18 years undergoing cardiovascular surgery

Inclusion criteria

patients who receive cardiovascular surgery

  • Patients participated voluntarily and signed informed consent

Exclusion criteria

Exclusion Criteria:

  • past medical history of neurological and psychiatric diseases; severe visual or hearing impairment;
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
113 participants (estimated)
Patient registry
No

Groups and cohorts

  • Delirium is determined by 3D-CAM score
  • No delirium is determined by 3D-CAM score
05

What researchers measure

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.

    Time frame: After surgery through to postoperative day 7

Secondary outcomes

  1. 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.

    Time frame: Perioperative data

  2. 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

    Time frame: Perioperative data

  3. 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

    Time frame: Perioperative data

  4. 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

    Time frame: Perioperative data

06

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
    Recruiting
07

Registry details

Key details

Study ID
NCT06007755
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Hua Zheng (Associate Professor, Huazhong University of Science and Technology) — Principal investigator
First posted
Aug 23, 2023
Start date
Sep 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Hua Zheng, Dr.
Contact
hzheng@hust.edu.cn
0086-27-83663173

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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