DeliriumNCT06194474
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
An observational study of Delirium, run by Jining First People's Hospital at 1 site in China.
Trial summary
To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Delirium
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to Feb 2024
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.
Who may be able to join
- patients between 55 and 80 years old,
- American Society of Anesthesiologists (ASA) physical status of II-III and New York Heart Association grade of II-III.
- The planned cardiac surgery.
- Hospitalization duration not less than 5 days.
- The anesthesia time will be no less than 2 hours.All patients had a normal ability to hear, read and cooperate with neuropsychological tests.
Who cannot join
- The pre-operative Montreal Cognitive Assessment (MoCA) score was less than 25,
- Patients with dementia, history of neurological or psychiatric disease, hospital with anxiety depression scale (HADS) over eight points,
- Currently use sedatives or antidepressants, Patients with substance dependence on drugs or alcohol.
- Patients with liver and kidney dysfunction, patients with a history of cardiac surgery.
- Admitted to the ICU for more than two days within the month preceding the current surgery,
- Unable to cooperate with researcher's investigations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuhui Yan
Jining, Shandong, 272000
Fuhui Yan, 15587335175, richardcarryon@163.com
About this study
To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.
- Conditions
- Delirium
- Medical subject headings
- 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 |
|---|---|---|
| Delirium Group | Not described | |
| No Delirium Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomics
Proteomic data will be obtained by LC-MS/MS Analysis-DIA(Data Independent Acquisition) platform
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start5 Sep 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jining First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuhui Yan, Jining First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194474
- Sponsor's protocol ID
- JNFPH-2023-01
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06194474
- Acronym / sponsor ID
- JNFPH-2023-01
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jining First People's HospitalUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium Group | – | – |
| No Delirium Group | – | – |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.
Key inclusion criteria (5 listed)
- patients between 55 and 80 years old,
- American Society of Anesthesiologists (ASA) physical status of II-III and New York Heart Association grade of II-III.
- The planned cardiac surgery.
- Hospitalization duration not less than 5 days.
- The anesthesia time will be no less than 2 hours.All patients had a normal ability to hear, read and cooperate with neuropsychological tests.
Key exclusion criteria (6 listed)
- The pre-operative Montreal Cognitive Assessment (MoCA) score was less than 25,
- Patients with dementia, history of neurological or psychiatric disease, hospital with anxiety depression scale (HADS) over eight points,
- Currently use sedatives or antidepressants, Patients with substance dependence on drugs or alcohol.
- Patients with liver and kidney dysfunction, patients with a history of cardiac surgery.
- Admitted to the ICU for more than two days within the month preceding the current 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
Proteomics
Time frame: 1 month
Proteomic data will be obtained by LC-MS/MS Analysis-DIA(Data Independent Acquisition) platform
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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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.
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 Delirium, run by Jining First People's 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 5 inclusion and 6 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 8 Jan 2024. 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 Fuhui Yan (155 8733 5175 ext. 86, richardcarryon@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics (time frame: 1 month). 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 8 Jan 2024.