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

NCT03915314 | Unknown

• 1 other identifier: XYFY2018-KL091-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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 .

Conditions

Postoperative Delirium; Elective Non-Cardiac Surgery

Keywords

delirium; blood biomakers; endothelial dysfunction; blood brain barrier (BBB)

Outcome Measures

Primary Outcomes (4)

• 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

• serum concentration change in biomarker of blood brain barrier disruption

  caveolin-1 to be measured at 2 time points

  baseline, postoperative day 1

• serum concentration change in biomarker of neuronal injury

  Neurofilament light (NfL) to be measured at 2 time points

  baseline, postoperative day 1

• 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 Outcomes (4)

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

  1 day before the surgery(baseline)

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

  1 day after the surgery

• The severity of pain at baseline

  1 day before the surgery(baseline)

• The severity of pain after surgry

  From day 0 to up to 3 days after the surgery

Study Arms (2)

POD group

POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method.

Diagnostic Test: Neuropsychological tests

Non-POD group

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

Diagnostic Test: Neuropsychological tests

Interventions

Neuropsychological tests DIAGNOSTIC_TEST

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; POD group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥60 years undergoing elective non-cardiac major surgery under general anesthesia were investigated.

You may qualify if:

• Patients undergoing selective major noncardiac surgery and general anesthesia;
• Age 60-90 yrs;
• Anesthesia Society of American (ASA) Scale II\~III;
• Anticipated surgery time 2-6 hrs
• Written informed consent;

You may not qualify if:

• decline to participate
• Dementia patients（Mini-mental state examination\< 20）
• Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

Junli Cao

Xuzhou, Jiangsu, 221000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine and blood

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

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

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 16, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CN (1)