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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05772026
Other study ID # XuzhouCH2023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 20, 2023
Est. completion date January 1, 2025

Study information

Verified date February 2023
Source Xuzhou Central Hospital
Contact Yangzi Zhu, Doctor
Phone +86 18168779150
Email zhuyz@188.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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-?. 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Xuzhou Central Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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