Correlation Between Urine UACR and Postoperative Neurocognitive Disorder in Elderly Patients With Non-cardiac Surgery

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 Overview

• Status: Unknown
• Conditions: Delirium; Postoperative Cognitive Dysfunction
• Intervention / Treatment: Diagnostic test: Neuropsychological tests

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
      • Contact: Cao Junli; Phone Number: +86 15162160809; Email: caojl0310@yahoo.com.cn
      • Contact: Han Yuan; Phone Number: +86 13852470693; Email: hanyuan_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We included 400 patients undergoing non-cardiac surgery at the affiliated hospital of Xuzhou Medical University.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Neuropsychological tests; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	before discharge from PACU
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	morning of the 1st day after surgery
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	afternoon of the 1st day after surgery
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	morning of the 2st day after surgery
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	afternoon of the 2st day after surgery
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	morning of the 3st day after surgery
Confusion Assessment Method（CAM)	Confusion Assessment Method to measure delirium	afternoon of the 3st day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	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.	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.	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.	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.	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.	afternoon of the 3st day after surgery
Mini-Mental score examination (MMSE)	Mini-Mental score examination [MMSE] used for screening of dementia	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	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	one month after surgery
serum folic acid levels	Record preoperative serum folic acid levels	1 day before surgery(baseline)
serum vitamin B12 levels	Record preoperative serum vitamin B12 levels	1 day before surgery(baseline)
serum homocysteine content	Record preoperative serum homocysteine content	1 day before surgery(baseline)
serum branched chain amino acid content	Record preoperative serum branched chain amino acid content	1 day before surgery(baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood Albumin levels	Record preoperative blood Albumin levels	before surgery(baseline)
blood Hemoglobin content	Record preoperative blood Hemoglobin content	before surgery(baseline)
blood Alanine aminotransferase （ALT） levels	Record preoperative blood Alanine aminotransferase （ALT） levels	before surgery(baseline)
blood Aspartate aminotransferase （AST）levels	Record preoperative blood Aspartate aminotransferase （AST）levels	before surgery(baseline)
Blood urea nitrogen（BUN） levels	Record preoperative Blood urea nitrogen（BUN） levels	before surgery(baseline)
Blood creatinine（Cr） levels	Record preoperative Blood creatinine（Cr） levels	before surgery(baseline)

Collaborators and Investigators

• Sponsor: Han Yuan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Delirium; Postoperative Cognitive Dysfunction; UACR
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications; Neurocognitive Disorders
• Other Study ID Numbers: XYFY2019-KL015-01