Postoperative Cognitive DysfunctionNCT03860714
Correlation Between Urine UACR and Postoperative Neurocognitive Disorder in Elderly Patients With Non-cardiac Surgery
An observational study of Postoperative Cognitive Dysfunction and Delirium, run by Han Yuan at 1 site in China.
Trial summary
This study intends to evaluate the relationship between urinary albumin/creatinine ratio and postoperative neurocognitive impairment in elderly non-cardiac surgery patients. The results of the study are to identify risk factors, screen high-risk populations to improve clinical evidence, early detection and early… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Delirium
- What is being tested?
- Neuropsychological tests
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 May 2020
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included 400 patients undergoing non-cardiac surgery 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; ③Han 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 people signed informed consent.
Who cannot join
- The diagnosis of preoperative delirium；
- The diagnosis Unstable hypertension（Such as：pheochromocytoma or aortic dissection）； ③Severe chronic obstructive pulmonary disease or congestive heart failure； ④Severe liver and kidney dysfunction;
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
Cao Junli, +86 15162160809, caojl0310@yahoo.com.cn
Han Yuan, +86 13852470693, hanyuan_trial@163.com
About this study
This study intends to evaluate the relationship between urinary albumin/creatinine ratio and postoperative neurocognitive impairment in elderly non-cardiac surgery patients. The results of the study are to identify risk factors, screen high-risk populations to improve clinical evidence, early detection and early treatment.And reducing the burden of PNCD on patients and their families, hospitals and public resources.
- Conditions
- Postoperative Cognitive Dysfunction, Delirium
- Being tested
- Neuropsychological tests
- Keywords
- Postoperative Cognitive Dysfunction, Delirium, UACR
- Medical subject headings
- Postoperative Cognitive Complications, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic test
We do the neuropsychological tests, Mini-Mental score examination (MMSE),Charlson Comorbidity Index(CCI)，Clinical Dementia Rating(CDR),Quality of Recovery Score - 40 (QoR-40),Geriatric Depression Scale (GDS),CAGE Alcoholism Questionnaire，Pure Tone Audiometry，blood albumin、hemoglobin content、ALT、AST、BUN、Cr、serum folic acid、vitamin B12、homocysteine and branched chain amino acid content 1 day before the surgery（baseline）； 1 day before the surgery（baseline）； Confusion Assessment Method（CAM)，Numerical Rating Scale（NRS）once before discharge from PACU and 1、2、3 days after surgery twice a day； QoR-40 1 day after surgery； Neuropsychological tests and MMSE 6±1 days and one month after surgery.
| Study group | Role | What they receive |
|---|---|---|
| study group | 400 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China].We do the neuropsychological tests,MMSE,CCI，CDR,QoR-40,GDS,CAGE Alcoholism Questionnaire，Pure Tone Audiometry，blood albumin、hemoglobin content、ALT、AST、BUN、Cr、serum folic acid、vitamin B12、homocysteine and branched chain amino acid content 1 day before the surgery（baseline）； 1 day before the surgery（baseline）； Confusion Assessment Method（CAM)，NRS once before discharge from PACU and 1、2、3 days after surgery twice a day； QoR-40 1 day after surgery； Neuropsychological tests and MMSE 6±1 days and one month after surgery. Receives: Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: before discharge from PACU
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: morning of the 1st day after surgery
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: afternoon of the 1st day after surgery
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: morning of the 2st day after surgery
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: afternoon of the 2st day after surgery
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: morning of the 3st day after surgery
Confusion Assessment Method（CAM)
Confusion Assessment Method to measure delirium
Measured: afternoon of the 3st day after surgery
Secondary outcomes (16)
Quality of Recovery Score - 40 (QoR-40)
Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
Measured: 1 day before surgery(baseline)
Quality of Recovery Score - 40 (QoR-40)
Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
Measured: 1 day after surgery
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: before discharge from PACU
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: morning of the 1st day after surgery
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: afternoon of the 1st day after surgery
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: morning of the 2st day after surgery
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: afternoon of the 2st day after surgery
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: morning of the 3st day after surgery
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Measured: afternoon of the 3st day after surgery
Mini-Mental score examination (MMSE)
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: 1 day before surgery(baseline)
Mini-Mental score examination (MMSE) and Neuropsychological tests
Mini-Mental score examination (MMSE) and Neuropsychological tests to measure cognitive function, including the Trail
Measured: 6±1 days after surgery
Mini-Mental score examination (MMSE) and Neuropsychological tests
Mini-Mental score examination (MMSE) and Neuropsychological tests to measure cognitive function, including the Trail
Measured: one month after surgery
serum folic acid levels
Record preoperative serum folic acid levels
Measured: 1 day before surgery(baseline)
serum vitamin B12 levels
Record preoperative serum vitamin B12 levels
Measured: 1 day before surgery(baseline)
serum homocysteine content
Record preoperative serum homocysteine content
Measured: 1 day before surgery(baseline)
serum branched chain amino acid content
Record preoperative serum branched chain amino acid content
Measured: 1 day before surgery(baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 May 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
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Han Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860714
- Sponsor's protocol ID
- XYFY2019-KL015-01
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Urine UACR and Postoperative Neurocognitive Disorder in Elderly Patients With Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT03860714
- Acronym / sponsor ID
- XYFY2019-KL015-01
- Conditions
- Postoperative Cognitive Dysfunction, Delirium
- Keywords
- Postoperative Cognitive Dysfunction, Delirium, UACR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Han YuanUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 4 Mar 2019 (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.
This study intends to evaluate the relationship between urinary albumin/creatinine ratio and postoperative neurocognitive impairment in elderly non-cardiac surgery patients. The results of the study are to identify risk factors, screen high-risk populations to improve clinical evidence, early detection and early treatment.And reducing the burden of PNCD on patients and their families, hospitals and public resources.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: Neuropsychological tests400 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China].We do the neuropsychological tests,MMSE,CCI，CDR,QoR-40,GDS,CAGE Alcoholism Questionnaire，Pure Tone Audiometry，blood albumin、hemoglobin content、ALT、AST、BUN、Cr、serum folic acid、vitamin B12、homocysteine and branched chain amino acid content 1 day before the surgery（baseline）； 1 day before the surgery（baseline）； Confusion Assessment Method（CAM)，NRS once before discharge from PACU and 1、2、3 days after surgery twice a day； QoR-40 1 day after surgery； Neuropsychological tests and MMSE 6±1 days and one month after surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included 400 patients undergoing non-cardiac surgery at the affiliated hospital of Xuzhou Medical University.
Key inclusion criteria (4 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 people signed informed consent.
Key exclusion criteria (2 listed)
- The diagnosis of preoperative delirium；
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 |
|---|---|---|
| Neuropsychological testsWe do the neuropsychological tests, Mini-Mental score examination (MMSE),Charlson Comorbidity Index(CCI)，Clinical Dementia Rating(CDR),Quality of Recovery Score - 40 (QoR-40),Geriatric Depression Scale (GDS),CAGE Alcoholism Questionnaire，Pure Tone Audiometry，blood albumin、hemoglobin content、ALT、AST、BUN、Cr、serum folic acid、vitamin B12、homocysteine and branched chain amino acid content 1 day before the surgery（baseline）； 1 day before the surgery（baseline）； Confusion Assessment Method（CAM)，Numerical Rating Scale（NRS）once before discharge from PACU and 1、2、3 days after surgery twice a day； QoR-40 1 day after surgery； Neuropsychological tests and MMSE 6±1 days and one month after surgery. | Diagnostic test | study group |
Primary outcome
Confusion Assessment Method（CAM)
Time frame: before discharge from PACU
Confusion Assessment Method to measure delirium
Confusion Assessment Method（CAM)
Time frame: morning of the 1st day after surgery
Confusion Assessment Method to measure delirium
Confusion Assessment Method（CAM)
Time frame: afternoon of the 1st day after surgery
Confusion Assessment Method to measure delirium
Confusion Assessment Method（CAM)
Time frame: morning of the 2st day after surgery
Confusion Assessment Method to measure delirium
Confusion Assessment Method（CAM)
Time frame: afternoon of the 2st day after surgery
Confusion Assessment Method to measure delirium
Confusion Assessment Method（CAM)
Time frame: morning of the 3st day after surgery
Confusion Assessment Method to measure delirium
Confusion Assessment Method（CAM)
Time frame: afternoon of the 3st day after surgery
Confusion Assessment Method to measure delirium
16 secondary outcomes
Quality of Recovery Score - 40 (QoR-40)
Time frame: 1 day before surgery(baseline)
Quality of Recovery Score - 40 (QoR-40)
Time frame: 1 day after surgery
Numerical Rating Scale（NRS）
Time frame: before discharge from PACU
Numerical Rating Scale（NRS）
Time frame: morning of the 1st day after surgery
Numerical Rating Scale（NRS）
Time frame: afternoon of the 1st day after surgery
Numerical Rating Scale（NRS）
Time frame: morning of the 2st day after surgery
Numerical Rating Scale（NRS）
Time frame: afternoon of the 2st day after surgery
Numerical Rating Scale（NRS）
Time frame: morning of the 3st day after surgery
Numerical Rating Scale（NRS）
Time frame: afternoon of the 3st day after surgery
Mini-Mental score examination (MMSE)
Time frame: 1 day before surgery(baseline)
Mini-Mental score examination (MMSE) and Neuropsychological tests
Time frame: 6±1 days after surgery
Mini-Mental score examination (MMSE) and Neuropsychological tests
Time frame: one month after surgery
serum folic acid levels
Time frame: 1 day before surgery(baseline)
serum vitamin B12 levels
Time frame: 1 day before surgery(baseline)
serum homocysteine content
Time frame: 1 day before surgery(baseline)
serum branched chain amino acid content
Time frame: 1 day before surgery(baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
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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 and Delirium, run by Han Yuan 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 4 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 4 Mar 2019. 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?
Confusion Assessment Method（CAM) (time frame: before discharge from PACU). The study lists 7 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 4 Mar 2019.