Perioperative Neurocognitive DisordersNCT06334289
A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery
An observational study of Perioperative Neurocognitive Disorders and Frail Elderly, run by Qianfoshan Hospital.
Trial summary
Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Neurocognitive Disorders, Frail Elderly
- How many people
- 338 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing gastrointestinal surgery under general anesthesia.
Who may be able to join
- Age ≥ 65 years old
- American Society of Anesthesiologists (ASA) classification: grades I-IV
- Hospitalization time ≥ 3 days
Who cannot join
- The revised version of the Cognitive Function Telephone Questionnaire (TICS-M) was used before surgery to determine cognitive impairment (TICS-M score ≤ 27 points)
- Refuse to participate
- Emergency surgical patients
- Central nervous system diseases (dementia, depression, etc.)
- Severe renal insufficiency (requiring dialysis)
- Long term use of psychotropic drugs (such as clozapine, risperidone, olanzapine, haloperidol, chlorpromazine, etc.)
- History of alcohol abuse or use of acetylcholine drugs
- The same patient can only be included once, regardless of whether the reason for the second surgery is related to the first cause
Trial locations and contacts
No sites are listed yet.
About this study
Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery.
- Keywords
- Peripheral blood biomarkers, inflammatory markers, Alanine aminotransferase, blood lipids, vitamin D
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 |
|---|---|---|
| Frailty group | Not described | |
| Non-frailty group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 7-day incidence of PND
The primary outcome of this study is the postoperative 7-day incidence of PND Blood samples (approximately 3ml each time) were taken before anesthesia induction and after the removal of the tracheal catheter, and then standardized tests were performed to analyze the blood markers related to this study. The follow-up method used was the revised version of the Cognitive Function Telephone Questionnaire (TICS-M), and the scores were evaluated through telephone follow-up. Screening was conducted one day before surgery, and follow-up and diagnosis were conducted on the 7th and 30th days after surgery. When the reliable change index of TICS-M score decreases by 1-2, POCD is considered mild. When the reliable change index of TICS-M score decreases by ≥ 2, POCD is considered severe. After follow-up, the values of serum biomarkers were obtained from two groups of patients for data analysis, and the correlation between the biomarkers and the two groups was obtained.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Sun, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334289
- Sponsor's protocol ID
- YXLL-KY-2024(017)
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06334289
- Acronym / sponsor ID
- YXLL-KY-2024(017)
- Keywords
- Peripheral blood biomarkers, inflammatory markers, Alanine aminotransferase, blood lipids, vitamin D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Mar 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.
Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frailty group | – | – |
| Non-frailty group | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing gastrointestinal surgery under general anesthesia.
Key inclusion criteria (3 listed)
- Age ≥ 65 years old
- American Society of Anesthesiologists (ASA) classification: grades I-IV
- Hospitalization time ≥ 3 days
Key exclusion criteria (8 listed)
- The revised version of the Cognitive Function Telephone Questionnaire (TICS-M) was used before surgery to determine cognitive impairment (TICS-M score ≤ 27 points)
- Refuse to participate
- Emergency surgical patients
- Central nervous system diseases (dementia, depression, etc.)
- Severe renal insufficiency (requiring dialysis)
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
Postoperative 7-day incidence of PND
Time frame: 30 days after surgery
The primary outcome of this study is the postoperative 7-day incidence of PND Blood samples (approximately 3ml each time) were taken before anesthesia induction and after the removal of the tracheal catheter, and then standardized tests were performed to analyze the blood markers related to this study. The follow-up method used was the revised version of the Cognitive Function Telephone Questionnaire (TICS-M), and the scores were evaluated through telephone follow-up. Screening was conducted one day before surgery, and follow-up and diagnosis were conducted on the 7th and 30th days after surgery. When the reliable change index of TICS-M score decreases by 1-2, POCD is considered mild. When the reliable change index of TICS-M score decreases by ≥ 2, POCD is considered severe. After follow-up, the values of serum biomarkers were obtained from two groups of patients for data analysis, and the correlation between the biomarkers and the two groups was obtained.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Neurocognitive Disorders and Frail Elderly, run by Qianfoshan 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 8 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 28 Mar 2024. 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 yong t Sun, Ph.D (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 7-day incidence of PND (time frame: 30 days after surgery). 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 28 Mar 2024.