Postoperative DeliriumNCT05164965
C-reactive Protein，Homocysteine，Postoperative Delirium
An observational study of Postoperative Delirium, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate how C-reactive protein (CRP) and homocysteine and their interaction contribute to postoperative delirium, based on our previous finding on the interactions of CRP, homocysteine and postoperative delirium. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 30 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 60 years old or older and scheduled for orthopedic surgeries with an expected duration ≥ 2 h
Who may be able to join
- were 60 years old or older
- had a normal cognitive function at the time of enrollment, evidenced by a mini-mental state examination (MMSE) score above an education-adjusted threshold (18 for individuals with no school education, 20 for 1-6 years of education, or 24 for 7 or more years of education 27)
- spoke Mandarin Chinese
- were able to provide informed consent
- scheduled for orthopaedic surgeries
Who cannot join
- pre-existing delirium assessed according to the Confusion Assessment Method (CAM) algorithm;
- prior neurologic diseases (Parkinson's disease, multiple sclerosis or stroke) according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10);
- history of mental disorders, e.g., major depressive disorder and schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV);
- unwillingness to comply with the assessments.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: C-reactive Protein and Homocysteine and Their Interaction Contribute to Postoperative Delirium
The aim of this study is to evaluate how C-reactive protein (CRP) and homocysteine and their interaction contribute to postoperative delirium, based on our previous finding on the interactions of CRP, homocysteine and postoperative delirium.
Read the detailed description
Postoperative delirium is a common complication of patients who undergo major surgery. It is frequently accompanied by adverse outcomes like Alzheimer's disease, high risk of postoperative complications and poor long-term outcomes, but its pathogenesis and biomarkers remain undetermined. Neuroinflammation is emerging as a popular hypothesis of developing postoperative delirium, particularly via microglial activation and increased pro-inflammatory cytokines in the brain. However, not every patient with surgery-induced inflammation develops postoperative delirium. Thus, inflammation alone may be insufficient to explain postoperative delirium. Patients who develop postoperative delirium may have other changes (predisposing factors) that exacerbate surgery-induced inflammation (precipitating factor), leading to neuronal dysfunction.
A potential predisposing factor is hyperhomocysteine, a pathogenesis implicated in cardiovascular and Alzheimer's disease. Previous studies had indicated that preoperative hyperhomocysteine may be related to postoperative delirium, but the findings are conflicting. More importantly, the interaction between inflammation and hyperhomocysteine remains unknown, which may contribute more to postoperative delirium than the inflammation alone or hyperhomocysteine alone.
Thus, this study is a prospective observational cohort study to evaluate the interaction between CRP and hyperhomocysteine and their contribution to postoperative delirium. Patients scheduled for orthopedic surgeries will be included. Written informed consent will be obtained from all the patients.
Preoperative assessments：Participants recruited will receive preoperative assessments one day before the scheduled surgery by two well-trained researchers. The assessments include demographic characteristics (e.g., age, sex, education, marital status )，age-adjusted Charlson comorbidity index (ACCI) , cognitive function assessments (mini-mental state examination [MMSE] and Confusion Assessment Method [CAM]). And similarly venous blood samples of patient will be collected for homocysteine and C-reactive protein measurements.
Outcome measurement： Postoperative delirium will be assessed for the first, second and third day after surgery (twice daily, in the morning and afternoon respectively) using the CAM and CAM-Severity (CAM-S) long-form by two trained assessors. And venous blood samples of patients will be collected after the anesthesia/surgery for C-reactive protein measurements.
- Conditions
- Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Incidence of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to the confusion assessment methods (CAM).
Measured: 3 days after surgery
Secondary outcomes (1)
Severity of postoperative delirium
Severity of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe).
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start10 Jan 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital
- Responsible party
- Principal investigator, Yuan Shen, MD, PhD, Shanghai 10th People's Hospital
- Investigators
- Yuan Shen, MD, PhD, Principal investigator, Shanghai, Shanghai, China, 200072
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164965
- Sponsor's protocol ID
- dsyy007
- Status last verified
- Dec 2021
- First submitted
- 10 Sep 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-reactive Protein and Homocysteine and Their Interaction Contribute to Postoperative Delirium
- ClinicalTrials.gov ID
- NCT05164965
- Acronym / sponsor ID
- dsyy007
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Dec 2021 (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.
The aim of this study is to evaluate how C-reactive protein (CRP) and homocysteine and their interaction contribute to postoperative delirium, based on our previous finding on the interactions of CRP, homocysteine and postoperative delirium.
Detailed description
Postoperative delirium is a common complication of patients who undergo major surgery. It is frequently accompanied by adverse outcomes like Alzheimer's disease, high risk of postoperative complications and poor long-term outcomes, but its pathogenesis and biomarkers remain undetermined. Neuroinflammation is emerging as a popular hypothesis of developing postoperative delirium, particularly via microglial activation and increased pro-inflammatory cytokines in the brain. However, not every patient with surgery-induced inflammation develops postoperative delirium. Thus, inflammation alone may be insufficient to explain postoperative delirium. Patients who develop postoperative delirium may have other changes (predisposing factors) that exacerbate surgery-induced inflammation (precipitating factor), leading to neuronal dysfunction.
A potential predisposing factor is hyperhomocysteine, a pathogenesis implicated in cardiovascular and Alzheimer's disease. Previous studies had indicated that preoperative hyperhomocysteine may be related to postoperative delirium, but the findings are conflicting. More importantly, the interaction between inflammation and hyperhomocysteine remains unknown, which may contribute more to postoperative delirium than the inflammation alone or hyperhomocysteine alone.
Thus, this study is a prospective observational cohort study to evaluate the interaction between CRP and hyperhomocysteine and their contribution to postoperative delirium. Patients scheduled for orthopedic surgeries will be included. Written informed consent will be obtained from all the patients.
Preoperative assessments：Participants recruited will receive preoperative assessments one day before the scheduled surgery by two well-trained researchers. The assessments include demographic characteristics (e.g., age, sex, education, marital status )，age-adjusted Charlson comorbidity index (ACCI) , cognitive function assessments (mini-mental state examination [MMSE] and Confusion Assessment Method [CAM]). And similarly venous blood samples of patient will be collected for homocysteine and C-reactive protein measurements.
Outcome measurement： Postoperative delirium will be assessed for the first, second and third day after surgery (twice daily, in the morning and afternoon respectively) using the CAM and CAM-Severity (CAM-S) long-form by two trained assessors. And venous blood samples of patients will be collected after the anesthesia/surgery for C-reactive protein measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 60 years old or older and scheduled for orthopedic surgeries with an expected duration ≥ 2 h
Key inclusion criteria (5 listed)
- were 60 years old or older
- had a normal cognitive function at the time of enrollment, evidenced by a mini-mental state examination (MMSE) score above an education-adjusted threshold (18 for individuals with no school education, 20 for 1-6 years of education, or 24 for 7 or more years of education 27)
- spoke Mandarin Chinese
- were able to provide informed consent
- scheduled for orthopaedic surgeries
Key exclusion criteria (4 listed)
- pre-existing delirium assessed according to the Confusion Assessment Method (CAM) algorithm;
- prior neurologic diseases (Parkinson's disease, multiple sclerosis or stroke) according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10);
- history of mental disorders, e.g., major depressive disorder and schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV);
- unwillingness to comply with the assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium
Time frame: 3 days after surgery
Incidence of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to the confusion assessment methods (CAM).
1 secondary outcome
Severity of postoperative delirium
Time frame: 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Yuan Shen, MD, PhD principal investigator
Shanghai, Shanghai, China, 200072
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, run by Shanghai 10th People's Hospital 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 4 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 11 Jan 2022. 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 Yuan Shen, MD, PhD (2166303649, kmshy@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: 3 days after surgery). 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 11 Jan 2022.