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NCT Number: NCT06007755

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Hua Zheng, Dr

CONTACT

[email protected]

+86 18672750530

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: After surgery through to postoperative day 7

    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.

Secondary outcomes

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

    Time frame: Perioperative data

    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.

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

    Time frame: Perioperative data

    the level of Aβ in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor

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

    Time frame: Perioperative data

    the level of tau in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor

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

    Time frame: Perioperative data

    the level of exosomes in serum was determined by colorimetric and surface-enhanced Raman scattering (SERS) dual-mode magnetic immunosensor

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zheng, Dr.

CONTACT

[email protected]

0086-27-83663173

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Apr 3, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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