Clinical trial NCT03860714: Correlation Between Urine UACR and Postoperative Neurocognitive Disorder in Elderly Patients With Non-cardiac Surgery
Official title: Correlation Between Urine UACR and Postoperative Neurocognitive Disorder in Elderly Patients With Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Delirium
Keywords: Postoperative Cognitive Dysfunction
Delirium
UACR
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included 400 patients undergoing non-cardiac surgery at the affiliated hospital of Xuzhou Medical University.

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Confusion Assessment Method（CAM)
timeFrame: before discharge from PACU
measure: Confusion Assessment Method（CAM)
timeFrame: morning of the 1st day after surgery
measure: Confusion Assessment Method（CAM)
timeFrame: afternoon of the 1st day after surgery
measure: Confusion Assessment Method（CAM)
timeFrame: morning of the 2st day after surgery
measure: Confusion Assessment Method（CAM)
timeFrame: afternoon of the 2st day after surgery
measure: Confusion Assessment Method（CAM)
timeFrame: morning of the 3st day after surgery
measure: Confusion Assessment Method（CAM)
timeFrame: afternoon of the 3st day after surgery
Secondary outcomes:
measure: Quality of Recovery Score - 40 (QoR-40)
timeFrame: 1 day before surgery(baseline)
measure: Quality of Recovery Score - 40 (QoR-40)
timeFrame: 1 day after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: before discharge from PACU
measure: Numerical Rating Scale（NRS）
timeFrame: morning of the 1st day after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: afternoon of the 1st day after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: morning of the 2st day after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: afternoon of the 2st day after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: morning of the 3st day after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: afternoon of the 3st day after surgery
measure: Mini-Mental score examination (MMSE)
timeFrame: 1 day before surgery(baseline)
measure: Mini-Mental score examination (MMSE) and Neuropsychological tests
timeFrame: 6±1 days after surgery
measure: Mini-Mental score examination (MMSE) and Neuropsychological tests
timeFrame: one month after surgery
measure: serum folic acid levels
timeFrame: 1 day before surgery(baseline)
measure: serum vitamin B12 levels
timeFrame: 1 day before surgery(baseline)
measure: serum homocysteine content
timeFrame: 1 day before surgery(baseline)
measure: serum branched chain amino acid content
timeFrame: 1 day before surgery(baseline)
Other outcomes:
measure: blood Albumin levels
timeFrame: before surgery(baseline)
measure: blood Hemoglobin content
timeFrame: before surgery(baseline)
measure: blood Alanine aminotransferase （ALT） levels
timeFrame: before surgery(baseline)
measure: blood Aspartate aminotransferase （AST）levels
timeFrame: before surgery(baseline)
measure: Blood urea nitrogen（BUN） levels
timeFrame: before surgery(baseline)
measure: Blood creatinine（Cr） levels
timeFrame: before surgery(baseline)
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References: