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Clinical Trials/NCT06007755
NCT06007755
Recruiting
Not Applicable

Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

Huazhong University of Science and Technology2 sites in 1 country113 target enrollmentSeptember 1, 2023
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Delirium is determined by 3D-CAM score
Conditions
Delirium
Sponsor
Huazhong University of Science and Technology
Enrollment
113
Locations
2
Primary Endpoint
Incidence of postoperative delirium
Status
Recruiting
Last Updated
29 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
December 1, 2027
Last Updated
29 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hua Zheng

Associate Professor

Huazhong University of Science and Technology

Eligibility Criteria

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;

Arms & Interventions

Delirium is determined by 3D-CAM score

No delirium is determined by 3D-CAM score

Outcomes

Primary Outcomes

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

  • 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 Sites (2)

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