Postoperative DeliriumNCT05772026
Plasma Proteomics in Patients With Postoperative Delirium
An observational study of Postoperative Delirium, run by Xuzhou Central Hospital.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2023to 1 Jan 2025
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing cardiac Surgery.
Who may be able to join
- 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-Ⅲ.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serum Biomarkers for Postoperative Delirium Based on Plasma Proteomic Analysis of Elder Patients Undergoing Cardiac Surgery
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.
Read the detailed 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.
- 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 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.
Measured: 1 day before surgery
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.
Measured: 2 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start20 Mar 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yangzi Zhu, Doctor, Study director, Xuzhou Central HospitalLiwei Wang, Doctor, Principal investigator, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772026
- Sponsor's protocol ID
- XuzhouCH2023
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Biomarkers for Postoperative Delirium Based on Plasma Proteomic Analysis of Elder Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05772026
- Acronym / sponsor ID
- XuzhouCH2023
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 Mar 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.
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.
Detailed 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.
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
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing cardiac Surgery.
Key inclusion criteria (3 listed)
- 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-Ⅲ.
Key exclusion criteria (4 listed)
- 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.
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 of Quantitative Proteomics between POD and non-POD
Time frame: 1 day before surgery
Plasma was isolated from peripheral blood for subsequent proteomic analysis. Investigators study the characteristics of proteins at a large-scale level.
Differences of Quantitative Proteomics between POD and non-POD after surgery
Time frame: 2 day after surgery
Plasma was isolated from peripheral blood for subsequent proteomic analysis. Investigators study the characteristics of proteins at a large-scale level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
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 study director
Xuzhou Central Hospital
Liwei Wang, Doctor principal investigator
Xuzhou Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Xuzhou Central Hospital.
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 4 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 of Quantitative Proteomics between POD and non-POD (time frame: 1 day before 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 16 Mar 2023.