Postoperative Cognitive DysfunctionNCT03703973
Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery
An observational study of Postoperative Cognitive Dysfunction, run by Xuzhou Medical University at 1 site in China.
Trial summary
To study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。 Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Neuropsychology test
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 31 Dec 2020
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We included 1000 Male and female patients undergoing non-cardiac surgery and 50 healthy volunteers at the affiliated hospital of Xuzhou Medical University.
Who may be able to join
- Non-cardiac surgery patients;
- Age is greater than or equal to 65 years old;
- Han Nationality, mother tongue is chinese;
- ④The MMSE score:Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;
- ⑤The Geriatric Depression Scale (GDS) grade 1 or 2;
- ⑥The important function without serious heart, brain, liver, kidney, lung and other organs;
- The ASA class I or II;
- The people signed informed consent.
Who cannot join
- The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; ②Had severe head and face disease, trauma history or history of surgery;
- Had a history of influenza in 3 weeks; ④The serious body disease and tobacco, wine and other substance abuse history; ⑤The presence of malignant tumor with shorter survival disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Junli Cao, +86 15162160809, caojl0310@yahoo.com.cn
Yuan Han, +86 13852470693, hanyuan_trial@163.com
About this study
To study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Neuropsychology test
- Keywords
- Postoperative Cognitive Dysfunction, Leukocyte Telomere Length
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychology testDiagnostic test
We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.
| Study group | Role | What they receive |
|---|---|---|
| study group | 1000 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.We also measure their preoperative leukocyte telomere length. Receives: Diagnostic Test: Neuropsychology test | |
| control group | We enroll 50 healthy volunteers and do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test at 1 day (baseline), 1 week, 3 months, 1 year and 3 years without safety issue. Receives: Diagnostic Test: Neuropsychology test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: 1 day before surgery(baseline)
the leukocyte telomere length
Measured: on the surgery day
the neuropsychological test to measure cognitive function
Measured: within the first 7 days (plus or minus 2 days) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: within the first 7 days (plus or minus 2 days) after surgery
the neuropsychological test to measure cognitive function
Measured: within the first 3 months (plus or minus 1 month) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: within the first 3 months (plus or minus 1 month) after surgery
the neuropsychological test to measure cognitive function
Measured: within the first 1 year (plus or minus 3 months) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: within the first 1 year (plus or minus 3 months) after surgery
the neuropsychological test to measure cognitive function
Measured: within the first 3 years (plus or minus 1 year) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: within the first 3 years (plus or minus 1 year) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Aug 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703973
- Sponsor's protocol ID
- POCDLTL
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT03703973
- Acronym / sponsor ID
- POCDLTL
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative Cognitive Dysfunction, Leukocyte Telomere Length
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Oct 2018 (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 study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: Neuropsychology test1000 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.We also measure their preoperative leukocyte telomere length. |
| control group | – | Diagnostic Test: Neuropsychology testWe enroll 50 healthy volunteers and do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test at 1 day (baseline), 1 week, 3 months, 1 year and 3 years without safety issue. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We included 1000 Male and female patients undergoing non-cardiac surgery and 50 healthy volunteers at the affiliated hospital of Xuzhou Medical University.
Key inclusion criteria (8 listed)
- Non-cardiac surgery patients;
- ④The MMSE score:Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;
- ⑤The Geriatric Depression Scale (GDS) grade 1 or 2;
- ⑥The important function without serious heart, brain, liver, kidney, lung and other organs;
Key exclusion criteria (2 listed)
- The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; ②Had severe head and face disease, trauma history or history of surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychology testWe do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue. | Diagnostic test | control group, study group |
Primary outcome
the neuropsychological test to measure cognitive function
Time frame: 1 day before surgery(baseline)
Mini-Mental score examination [MMSE] used for screening of dementia
Time frame: 1 day before surgery(baseline)
the leukocyte telomere length
Time frame: on the surgery day
the neuropsychological test to measure cognitive function
Time frame: within the first 7 days (plus or minus 2 days) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Time frame: within the first 7 days (plus or minus 2 days) after surgery
the neuropsychological test to measure cognitive function
Time frame: within the first 3 months (plus or minus 1 month) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Time frame: within the first 3 months (plus or minus 1 month) after surgery
the neuropsychological test to measure cognitive function
Time frame: within the first 1 year (plus or minus 3 months) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Time frame: within the first 1 year (plus or minus 3 months) after surgery
the neuropsychological test to measure cognitive function
Time frame: within the first 3 years (plus or minus 1 year) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Time frame: within the first 3 years (plus or minus 1 year) after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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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 Postoperative Cognitive Dysfunction, run by Xuzhou Medical University 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 8 inclusion and 2 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 12 Oct 2018. 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 Junli Cao (+86 15162160809, caojl0310@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neuropsychological test to measure cognitive function (time frame: 1 day before surgery(baseline)). The study lists 11 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 12 Oct 2018.