- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743660
Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Jiangsu
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Xuzhou, Jiangsu, China, 221000
- Recruiting
- Xuzhou Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be over 50 years old;
- ASA Grade I-III;
- Heart surgery is planned under general anesthesia.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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POD group
According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
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non-POD group
According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in circRNA microarrays before and after surgery
Time Frame: 1 day before surgery,3 day after surgery
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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.
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1 day before surgery,3 day after surgery
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3-minute Diagnostic Interview for CAM
Time Frame: Consecutive 7 days after the surgery
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Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).
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Consecutive 7 days after the surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XuzhouCH20220629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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