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

NCT03860714 | Unknown

• 1 other identifier: XYFY2019-KL015-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 treatment.And reducing the burden of PNCD on patients and their families, hospitals and public resources.

Conditions

Postoperative Cognitive Dysfunction; Delirium

Keywords

Postoperative Cognitive Dysfunction; Delirium; UACR

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (16)

• Quality of Recovery Score - 40 (QoR-40)

  1 day before surgery(baseline)

• Quality of Recovery Score - 40 (QoR-40)

  1 day after surgery

• Numerical Rating Scale（NRS）

  before discharge from PACU

• Numerical Rating Scale（NRS）

  morning of the 1st day after surgery

• Numerical Rating Scale（NRS）

  afternoon of the 1st day after surgery

Other Outcomes (6)

• blood Albumin levels

  before surgery(baseline)

• blood Hemoglobin content

  before surgery(baseline)

• blood Alanine aminotransferase （ALT） levels

  before surgery(baseline)

Study Arms (1)

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

Interventions

Neuropsychological tests DIAGNOSTIC_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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Han Yuan: lead

Study Sites (1)

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine and blood

MeSH Terms

Conditions

Postoperative Cognitive Complications; Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Junli Cao

CONTACT

+86 15162160809; caojl0310@yahoo.com.cn

Yuan Han

CONTACT

+86 13852470693; hanyuan_trial@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor-in-charge of Anesthetist

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 4, 2019
• Study Start: January 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: May 30, 2020
• Last Updated: March 4, 2019

Record last verified: 2019-02

Locations

CN (1)