Clinical trial NCT05772026: Plasma Proteomics in Patients With Postoperative Delirium
Official title: Serum Biomarkers for Postoperative Delirium Based on Plasma Proteomic Analysis of Elder Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac Surgery.

Brief summary: Patients undergoing cardiac surgery were recruited. Baseline characteristics of all subjects were collected. The 3-minute Delirium diagnostic Scale (3D-CAM) was used to screen the POD group and non-POD group from the recruited subjects during the first 7 days after surgery. Peripheral blood samples were collected 1 day before surgery and 2 day after surgery. . Plasma was isolated from peripheral blood for subsequent proteomic analysis.

Detailed description: Patients undergoing noncardiac surgery were recruited. Baseline characteristics of all subjects were collected. The 3-minute Delirium diagnostic Scale (3D-CAM) was used to screen the POD group and non-POD group from the recruited subjects during the first 7 days after surgery. Peripheral blood samples were collected 1 day before surgery and 2 day after surgery. Plasma was isolated from peripheral blood for subsequent proteomic analysis. To study the characteristics of proteins on a large scale, including protein expression levels, post-translational modifications, protein-protein interactions, etc., so as to obtain a comprehensive understanding of disease occurrence, cell metabolism and other processes at the protein level. Assessment of imbalanced protein expression in peripheral blood using protein profiling may allow us to better understand the pathological changes occurring at the molecular level of POD. Early detection of patients at high risk of POD can optimize perioperative management and promote rapid postoperative recovery.

Eligibility criteria: Inclusion Criteria:

* Age ≥65 years old, regardless of gender.
* The patient had clear consciousness and no cognitive impairment, and could cooperate with the investigation and follow-up.
* The ASA classification is I-Ⅲ.

Exclusion Criteria:

* severe neurological or psychiatric disorders.
* drug and alcohol abuse.
* Patients with cognitive impairment caused by various reasons such as neuropsychiatric symptoms.
* Exclusion criteria included incomplete medical records and failure to complete the postoperative follow-up.

Primary outcomes:
measure: Differences of Quantitative Proteomics between POD and non-POD
timeFrame: 1 day before surgery
measure: Differences of Quantitative Proteomics between POD and non-POD after surgery
timeFrame: 2 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xuzhou Central Hospital
name: Yangzi Zhu, Doctor
role: STUDY_DIRECTOR
affiliation: Xuzhou Central Hospital
name: Liwei Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: