Postoperative DeliriumNCT05743660
Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery
An observational study of Postoperative Delirium, run by Xuzhou Central Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Postoperative Delirium
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing heart surgery
Who may be able to join
- Be over 50 years old;
- ASA Grade I-III;
- Heart surgery is planned under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Feng chunguang, PhD, +8618936376559, fcg999@163.com
Feng chunguang, PhD
About this study
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.
Read the 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.
- Conditions
- Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Consecutive 7 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start30 Jun 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yangzi Zhu, Doctor, Principal investigator, Xuzhou Central HospitalLiwei Wang, Doctor, Study director, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743660
- Sponsor's protocol ID
- XuzhouCH20220629
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05743660
- Acronym / sponsor ID
- XuzhouCH20220629
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing heart surgery
Key inclusion criteria (3 listed)
- Be over 50 years old;
- ASA Grade I-III;
- Heart surgery is planned under general anesthesia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in circRNA microarrays before and after surgery
Time frame: 1 day before surgery，3 day 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.
3-minute Diagnostic Interview for CAM
Time frame: Consecutive 7 days after the surgery
Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangzi Zhu, Doctor principal investigator
Xuzhou Central Hospital
Liwei Wang, Doctor study director
Xuzhou Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Xuzhou Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangzi Zhu, Doctor (+86 18168779150, zhuyz@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in circRNA microarrays before and after surgery (time frame: 1 day before surgery，3 day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.