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Recruiting NCT06007755

Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

Observational Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Delirium. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Incidence of postoperative delirium [Time frame: After surgery through to postoperative day 7]
Secondary outcome measures (4)
  • the level of H3K18 in serum monocytes of postoperative delirium and un-delirium patients [Time frame: Perioperative data]
  • the level of Aβ in serum of postoperative delirium and un-delirium patients [Time frame: Perioperative data]
  • the level of tau in serum of postoperative delirium and un-delirium patients [Time frame: Perioperative data]
  • the level of exosomes in serum of postoperative delirium and un-delirium patients [Time frame: Perioperative data]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University — Wuhan

Identifiers

NCT: NCT06007755 · TJMZK202301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗