Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery

NCT05743660 | Unknown

• 1 other identifier: XuzhouCH20220629
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The observational study aims to discover differentially expressed circRNAs in the peripheral blood of patients with postoperative delirium, which aims to answer the main questions at: Whether there are changes in circRNA expression in peripheral blood in elderly patients with delirium after cardiopulmonary bypass surgery? Whether the circRNA with altered expression plays an important role in the occurrence and development of POD? What are the functions and underlying mechanisms of circRNA with altered expression in POD? Voluntary patients will receive follow-up 1 day before and 7 days after surgery to assess their cognitive function, and peripheral blood will be collected 1 day before and 3 days after surgery. The study divided patients into POD group and non-POD group according to whether delirium occurred within 7 days after surgery.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• Differences in circRNA microarrays before and after surgery

  Plasma was isolated from peripheral blood, RNA samples were prepared, and circRNA microarray analysis was performed. The differences in circRNA expression in peripheral blood of POD patients and non-POD patients were comprehensively analyzed.

  1 day before surgery，3 day after surgery

• 3-minute Diagnostic Interview for CAM

  Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).

  Consecutive 7 days after the surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing heart surgery

You may qualify if:

• Be over 50 years old;
• ASA Grade I-III;
• Heart surgery is planned under general anesthesia.

You may not qualify if:

• Patients with the second surgery;
• The ejection fraction is less than 40%;
• The score of the preoperative simple mental status examination (MMSE) is less than 24 points;
• Patients with mental illness or central nervous system disease;
• Patients who cannot or refuse to complete MMSE before surgery.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma is isolated from peripheral blood to extract plasma

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yangzi Zhu, Doctor

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Liwei Wang, Doctor

  Xuzhou Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Yangzi Zhu, Doctor

CONTACT

+86 18168779150; zhuyz@188.com

Liwei Wang, Doctor

CONTACT

+86 18952170255; doctorlww@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: June 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)