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

April 11, 2019 updated by: Han Yuan, Xuzhou Medical University

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

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Junli Cao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, postoperative day 1
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
baseline, postoperative day 1
serum concentration change in biomarker of neuronal injury
Time Frame: baseline, postoperative day 1
Neurofilament light (NfL) to be measured at 2 time points
baseline, postoperative day 1
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.
From day 0 to up to 3 days after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
1 day before the surgery(baseline)
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).
1 day after the surgery
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.
1 day before the surgery(baseline)
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.
From day 0 to up to 3 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XYFY2018-KL091-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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