Postoperative DeliriumNCT03915314
Correlation Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery.
An observational study of Postoperative Delirium and Elective Non-Cardiac Surgery, run by Xuzhou Medical University at 1 site in China.
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 . Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Delirium, Elective Non-Cardiac Surgery
- What is being tested?
- Neuropsychological tests
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥60 years undergoing elective non-cardiac major surgery under general anesthesia were investigated.
Who may be able to join
- 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;
Who cannot join
- decline to participate
- Dementia patients（Mini-mental state examination< 20）
- Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junli Cao
Xuzhou, Jiangsu, 221000
Junli Cao, +86 15162160809, caojl0310@yahoo.com.cn
Yuan Han, +86 13852470693, hanyuan_trial@163.com
About this study
Official title: 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 .
Read the 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 .
- Being tested
- Neuropsychological tests
- Keywords
- delirium, blood biomakers, endothelial dysfunction, blood brain barrier (BBB)
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| POD group | POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method. Receives: Diagnostic Test: Neuropsychological tests | |
| Non-POD group | Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method. Receives: Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum concentration change in biomarker of endothelial dysfunction
C-terminal endothelin-1 (CT-proET-1) to be measured at 2 time points
Measured: baseline, postoperative day 1
serum concentration change in biomarker of blood brain barrier disruption
caveolin-1 to be measured at 2 time points
Measured: baseline, postoperative day 1
serum concentration change in biomarker of neuronal injury
Neurofilament light (NfL) to be measured at 2 time points
Measured: 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.
Measured: From day 0 to up to 3 days after the surgery
Secondary outcomes (4)
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).
Measured: 1 day before the surgery(baseline)
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).
Measured: 1 day after the surgery
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.
Measured: 1 day before the surgery(baseline)
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.
Measured: From day 0 to up to 3 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Apr 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915314
- Sponsor's protocol ID
- XYFY2018-KL091-01
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery Under General Anesthsia.
- ClinicalTrials.gov ID
- NCT03915314
- Acronym / sponsor ID
- XYFY2018-KL091-01
- Keywords
- delirium, blood biomakers, endothelial dysfunction, blood brain barrier (BBB)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD group | – | Diagnostic Test: Neuropsychological testsPOD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method. |
| Non-POD group | – | Diagnostic Test: Neuropsychological testsNon-POD refered to the patients who did not become delirious by the Confusion Assessment Method. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥60 years undergoing elective non-cardiac major surgery under general anesthesia were investigated.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- decline to participate
- Dementia patients（Mini-mental state examination< 20）
- Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testsThe 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. | Diagnostic test | Non-POD group, POD group |
Primary outcome
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
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
serum concentration change in biomarker of neuronal injury
Time frame: baseline, postoperative day 1
Neurofilament light (NfL) to be measured at 2 time points
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.
4 secondary outcomes
Quality of Recovery Score - 40 (QoR-40) at baseline
Time frame: 1 day before the surgery(baseline)
Quality of Recovery Score - 40 (QoR-40) after surgry
Time frame: 1 day after the surgery
The severity of pain at baseline
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Elective Non-Cardiac Surgery, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junli Cao (+86 15162160809, caojl0310@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum concentration change in biomarker of endothelial dysfunction (time frame: baseline, postoperative day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.