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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03860714
• Other study ID #: XYFY2019-KL015-01
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: February 2019
• Source: Xuzhou Medical University
• Contact: Junli Cao
• Phone: +86 15162160809
• Email: caojl0310[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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 people signed informed consent.

Exclusion Criteria:

• The diagnosis of preoperative delirium;

• The diagnosis Unstable hypertension(Such as:pheochromocytoma or aortic dissection); ?Severe chronic obstructive pulmonary disease or congestive heart failure; ?Severe liver and kidney dysfunction;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Neurocognitive Disorders
• Postoperative Cognitive Dysfunction

Intervention

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.

Locations

Country	Name	City	State
China	Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Han Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood Albumin levels	Record preoperative blood Albumin levels	before surgery(baseline)
Other	blood Hemoglobin content	Record preoperative blood Hemoglobin content	before surgery(baseline)
Other	blood Alanine aminotransferase (ALT) levels	Record preoperative blood Alanine aminotransferase (ALT) levels	before surgery(baseline)
Other	blood Aspartate aminotransferase (AST)levels	Record preoperative blood Aspartate aminotransferase (AST)levels	before surgery(baseline)
Other	Blood urea nitrogen(BUN) levels	Record preoperative Blood urea nitrogen(BUN) levels	before surgery(baseline)
Other	Blood creatinine(Cr) levels	Record preoperative Blood creatinine(Cr) levels	before surgery(baseline)
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	before discharge from PACU
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	morning of the 1st day after surgery
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	afternoon of the 1st day after surgery
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	morning of the 2st day after surgery
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	afternoon of the 2st day after surgery
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	morning of the 3st day after surgery
Primary	Confusion Assessment Method(CAM)	Confusion Assessment Method to measure delirium	afternoon of the 3st day after surgery
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mini-Mental score examination (MMSE)	Mini-Mental score examination [MMSE] used for screening of dementia	1 day before surgery(baseline)
Secondary	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
Secondary	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
Secondary	serum folic acid levels	Record preoperative serum folic acid levels	1 day before surgery(baseline)
Secondary	serum vitamin B12 levels	Record preoperative serum vitamin B12 levels	1 day before surgery(baseline)
Secondary	serum homocysteine content	Record preoperative serum homocysteine content	1 day before surgery(baseline)
Secondary	serum branched chain amino acid content	Record preoperative serum branched chain amino acid content	1 day before surgery(baseline)