Plasma Proteomics in Patients With Postoperative Delirium

Serum Biomarkers for Postoperative Delirium Based on Plasma Proteomic Analysis of Elder Patients Undergoing Cardiac Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac Surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
POD group; According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
non-POD group; According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences of Quantitative Proteomics between POD and non-POD	Plasma was isolated from peripheral blood for subsequent proteomic analysis. Investigators study the characteristics of proteins at a large-scale level.	1 day before surgery
Differences of Quantitative Proteomics between POD and non-POD after surgery	Plasma was isolated from peripheral blood for subsequent proteomic analysis. Investigators study the characteristics of proteins at a large-scale level.	2 day after surgery

Collaborators and Investigators

• Sponsor: Xuzhou Central Hospital
• Investigators: Study Director: Yangzi Zhu, Doctor, Xuzhou Central Hospital; Principal Investigator: Liwei Wang, Doctor, Xuzhou Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 20, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: XuzhouCH2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No