Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery

October 10, 2018 updated by: Han Yuan, Xuzhou Medical University
To study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Neuropsychology 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.
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.
Diagnostic test: Neuropsychology 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
the neuropsychological test to measure cognitive function
Time Frame: 1 day before surgery(baseline)
1 day before surgery(baseline)
Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame: 1 day before surgery(baseline)
1 day before surgery(baseline)
the leukocyte telomere length
Time Frame: on the surgery day
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
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
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
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
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
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
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
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
within the first 3 years (plus or minus 1 year) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POCDLTL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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