Clinical trial NCT05743660: Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery
Official title: Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing heart surgery

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.

Detailed description: Investigators combined qRT-PCR by performing circRNAs chip analysis to study differential expression of circRNAs in plasma samples of elderly patients with non-POD who underwent cardiac surgery under general anesthesia and cardiopulmonary bypass. Subsequently, miRNA binding sites and associated mRNAs are predicted by bioinformatics analysis. Moreover, we plan to construct predicted circN-MIRNA-MRNA co-expression networks to study the main functions and pathways of target genes, thereby attempting to provide a preliminary view of the potential role of a circRNA in POD. The study may provide an important perspective on the differential expression of circRNA in patients with POD, and may also provide insights into biomarkers and therapeutic targets of POD.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Differences in circRNA microarrays before and after surgery
timeFrame: 1 day before surgery，3 day after surgery
measure: 3-minute Diagnostic Interview for CAM
timeFrame: Consecutive 7 days after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Yangzi Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Central Hospital
name: Liwei Wang, Doctor
role: STUDY_DIRECTOR
References: