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

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ClinicalTrials.gov Identifier: NCT03915314
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

Brief 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 .

Condition or disease Intervention/treatment
Postoperative Delirium Elective Non-Cardiac Surgery Diagnostic Test: Neuropsychological tests

Detailed 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 .

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Association Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery Under General Anesthsia.
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
POD group
POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method.
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.

Non-POD group
Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method.
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.




Primary Outcome Measures :
  1. serum concentration change in biomarker of endothelial dysfunction [ Time Frame: baseline, postoperative day 1 ]
    C-terminal endothelin-1 (CT-proET-1) to be measured at 2 time points

  2. serum concentration change in biomarker of blood brain barrier disruption [ Time Frame: baseline, postoperative day 1 ]
    caveolin-1 to be measured at 2 time points

  3. serum concentration change in biomarker of neuronal injury [ Time Frame: baseline, postoperative day 1 ]
    Neurofilament light (NfL) to be measured at 2 time points

  4. The incidence of postoperative delirium [ Time Frame: From day 0 to up to 3 days after the surgery ]
    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.


Secondary Outcome Measures :
  1. Quality of Recovery Score - 40 (QoR-40) at baseline [ Time Frame: 1 day before the surgery(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).

  2. Quality of Recovery Score - 40 (QoR-40) after surgry [ Time Frame: 1 day after the surgery ]
    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).

  3. The severity of pain at baseline [ Time Frame: 1 day before the surgery(baseline) ]
    Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain.

  4. The severity of pain after surgry [ Time Frame: From day 0 to up to 3 days after the surgery ]
    Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain.


Biospecimen Retention:   Samples With DNA
urine and blood


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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged ≥60 years undergoing elective non-cardiac major surgery under general anesthesia were investigated.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915314


Contacts
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Contact: Junli Cao +86 15162160809 caojl0310@yahoo.com.cn
Contact: Yuan Han +86 13852470693 hanyuan_trial@163.com

Locations
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China, Jiangsu
Junli Cao Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Junli Cao    +86 15162160809    caojl0310@yahoo.com.cn   
Contact: Yuan Han    +86 13852470693    hanyuan_trial@163.com   
Sponsors and Collaborators
Xuzhou Medical University

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Responsible Party: Han Yuan, Director, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03915314     History of Changes
Other Study ID Numbers: XYFY2018-KL091-01
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Han Yuan, Xuzhou Medical University:
delirium
blood biomakers
endothelial dysfunction
blood brain barrier (BBB)

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders