Correlation Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery.

Postoperative Delirium Clinical Trial

Official title:

The Association Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery Under General Anesthsia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915314
• Other study ID #: XYFY2018-KL091-01
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: April 2020

Study information

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

Clinical Trial Summary

More than 20% of patients over 60 years old develop postoperative delirium following non-cardiac surgery . Delirium increases morbidity and mortality , and may lead to long-term cognitive impairment . The underlying mechanisms behind delirium are not understood , endothelial dysfunction and disruption of the blood brain barrier (BBB ) caused by perioperative systemic inflammation may play a important role in the development of delirium . This study intends to evaluate the relationship between neuroinflammation and postoperative delirium in elderly non-cardiac surgery patients . The results of the study are to identify risk factors and explore the biomarkers most closely linked to each step of the proposed pathway .

Description:

The investigators do the neuropsychological tests , Mini-Mental score examination (MMSE ) , Charlson Comorbidity Index (CCI ) , Quality of Recovery Score - 40 (QoR-40 ) 1 day before the surgery（baseline ) . Serum of the patients was collected before operation and at POD1 , and then detect the concentration change of biomarkers of endothelial dysfunction , blood brain barrier disruption and neuronal injury . Also , the patients were interviewed once before discharge from PACU and twice on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups . Meanwhile , the severity of pain (Numerical Rating Scale（NRS )) was evaluated at the same time and QoR-40 at 1 day after surgery .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing selective major noncardiac surgery and general anesthesia;

2. Age 60-90 yrs;

3. Anesthesia Society of American (ASA) Scale II~III;

4. Anticipated surgery time 2-6 hrs

5. Written informed consent;

Exclusion Criteria:

1. decline to participate

2. Dementia patients(Mini-mental state examination< 20)

3. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.

Related Conditions & MeSH terms

• Delirium
• Elective Non-Cardiac Surgery
• Postoperative Delirium

Intervention

Diagnostic Test:
• Neuropsychological tests
The investigators do the neuropsychological tests, Mini-Mental score examination (MMSE),Charlson Comorbidity Index(CCI),Quality of Recovery Score - 40 (QoR-40),CAGE Alcoholism Questionnaire,blood albumin?hemoglobin content?ALT?AST?BUN?Cr?1 day before the surgery(baseline);serum biomarkers of endothelial dysfunction,blood brain barrier disruption and neuronal injury to be measured at 2 time points,1 day before the surgery(baseline)and postoperative day 1; 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.

Locations

Country	Name	City	State
China	Junli Cao	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum concentration change in biomarker of endothelial dysfunction	C-terminal endothelin-1 (CT-proET-1) to be measured at 2 time points	baseline, postoperative day 1
Primary	serum concentration change in biomarker of blood brain barrier disruption	caveolin-1 to be measured at 2 time points	baseline, postoperative day 1
Primary	serum concentration change in biomarker of neuronal injury	Neurofilament light (NfL) to be measured at 2 time points	baseline, postoperative day 1
Primary	The incidence of postoperative delirium	The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups.	From day 0 to up to 3 days after the surgery
Secondary	Quality of Recovery Score - 40 (QoR-40) at baseline	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 the surgery(baseline)
Secondary	Quality of Recovery Score - 40 (QoR-40) after surgry	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 the surgery
Secondary	The severity of pain at baseline	Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain.	1 day before the surgery(baseline)
Secondary	The severity of pain after surgry	Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain.	From day 0 to up to 3 days after the surgery