Postoperative Cognitive DysfunctionNCT03084393
POCD: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
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 the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin B12 could be used as predictor(s) of… 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
- How many people
- 215 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 30 Apr 2018
- 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: The investigators included 215 Male and female patients undergoing non-cardiac surgery and 30 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 60 years old;
- Han Nationality, mother tongue is chinese;
- The 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;
- The Geriatric Depression Scale (GDS) grade 1 or 2;
- The 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.;
- Had severe head and face disease, trauma history or history of surgery;
- The serious body disease and tobacco, wine and other substance abuse history;
- The presence of malignant tumor with shorter survival disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
Official title: Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
To study on the Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- non-cardiac surgery, Postoperative Cognitive Dysfunction
- 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.
| Study group | Role | What they receive |
|---|---|---|
| study group | 215 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. The investigators do the Mini-Mental score examination (MMSE) and neuropsychological tests 1 day before (baseline) and 1 week after surgery without safety issue. Patients will be divided into POCD and non-POCD groups according to the two times tests. | |
| non-surgical group | The investigators enroll 30 healthy volunteers and do the Mini-Mental score examination (MMSE) and neuropsychological tests at 1 day (baseline) and1 week without safety issue. The exclusive purpose of the non-surgical group is to aid in the POCD calculation according to the ISPOCD 1 study definition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neuropsychological tests
the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement Test,the Finger Tapping Test, the Word Fluency Test and the Building Block Test.
Measured: 1 day before surgery(baseline)
Mini-Mental score examination [MMSE]
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: 1 day before surgery(baseline)
the neuropsychological tests
the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement,the Test Finger Tapping Test, the Word Fluency Test and the Building Block Test.
Measured: within the first 7 days (plus or minus 2 days) after surgery
Mini-Mental score examination [MMSE]
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: within the first 7 days (plus or minus 2 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 posted20 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
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
- NCT03084393
- Sponsor's protocol ID
- XYFY2017-KL004-01
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: within six months after the trial complete
Publications
Zhang ZF, Sun QC, Xu YF, Ding K, Dong MM, Han L, Abdul-Mannan, Han Y, Cao JL. Association between preoperative serum homocysteine and delayed neurocognitive recovery after non-cardiac surgery in elderly patients: a prospective observational study. Perioper Med (Lond). 2021 Nov 8;10(1):37. doi: 10.1186/s13741-021-00208-1.
PubMed 34743734
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
- ClinicalTrials.gov ID
- NCT03084393
- Acronym / sponsor ID
- XYFY2017-KL004-01
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- non-cardiac surgery, Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 20 Mar 2017 (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 the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –215 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. The investigators do the Mini-Mental score examination (MMSE) and neuropsychological tests 1 day before (baseline) and 1 week after surgery without safety issue. Patients will be divided into POCD and non-POCD groups according to the two times tests. |
| non-surgical group | – | –The investigators enroll 30 healthy volunteers and do the Mini-Mental score examination (MMSE) and neuropsychological tests at 1 day (baseline) and1 week without safety issue. The exclusive purpose of the non-surgical group is to aid in the POCD calculation according to the ISPOCD 1 study definition. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators included 215 Male and female patients undergoing non-cardiac surgery and 30 healthy volunteers at the affiliated hospital of Xuzhou Medical University.
Key inclusion criteria (8 listed)
- Non-cardiac surgery patients;
- Age is greater than or equal to 60 years old;
- Han Nationality, mother tongue is chinese;
- The 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;
- The Geriatric Depression Scale (GDS) grade 1 or 2;
Key exclusion criteria (4 listed)
- The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.;
- Had severe head and face disease, trauma history or history of surgery;
- The serious body disease and tobacco, wine and other substance abuse history;
- The presence of malignant tumor with shorter survival disease.
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
the neuropsychological tests
Time frame: 1 day before surgery(baseline)
the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement Test,the Finger Tapping Test, the Word Fluency Test and the Building Block Test.
Mini-Mental score examination [MMSE]
Time frame: 1 day before surgery(baseline)
Mini-Mental score examination [MMSE] used for screening of dementia
the neuropsychological tests
Time frame: within the first 7 days (plus or minus 2 days) after surgery
the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement,the Test Finger Tapping Test, the Word Fluency Test and the Building Block Test.
Mini-Mental score examination [MMSE]
Time frame: within the first 7 days (plus or minus 2 days) after surgery
Mini-Mental score examination [MMSE] used for screening of dementia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 34743734Zhang ZF, Sun QC, Xu YF, Ding K, Dong MM, Han L, Abdul-Mannan, Han Y, Cao JL. Association between preoperative serum homocysteine and delayed neurocognitive recovery after non-cardiac surgery in elderly patients: a prospective observational study. Perioper Med (Lond). 2021 Nov 8;10(1):37. doi: 10.1186/s13741-021-00208-1.
- Individual participant dataSharing planned: Yes. within six months after the trial complete
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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: finished, as of the sponsor's last update on 11 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neuropsychological tests (time frame: 1 day before surgery(baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084393, which also lists 1 linked publication.
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 11 Mar 2020.