Postoperative DeliriumNCT04923243
The Neuro-epigenetics Biomarkers of Postoperative Delirium in Elderly Patients Undergoing Hip/Knee Replacement
An observational study of Postoperative Delirium, run by Zhongnan Hospital at 1 site in China.
Trial summary
Introduction: Postoperative delirium (POD), an acute, transient, fluctuating disturbance in attention, cognition, and level of consciousness, is a common (15-53%) postoperative complication, and it is associated with longer hospital stays, worse functional outcomes, higher healthcare costs, and increased mortality. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- hip/knee replacement
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to Jun 2024
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients were at least 65 years old and were scheduled to have hip/knee replacement.
Who may be able to join
None listed.
Who cannot join
- a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
- patients diagnosed with malignant or benign tumors;
- Mini-Mental State Examination (MMSE) scores of 26 or less;
- American Society of Anesthesiologists (ASA) score greater than 3;
- a history of alcohol abuse and drug dependence;
- inability to read or severe visual or auditory deficits;
- unwillingness to comply with the protocol or procedures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Mian Peng, doctor, +86 18607151101, sophie_pm@msn.com
Qianwen He, doctor, +8615827481960, mos.cherry@163.com
About this study
Introduction: Postoperative delirium (POD), an acute, transient, fluctuating disturbance in attention, cognition, and level of consciousness, is a common (15-53%) postoperative complication, and it is associated with longer hospital stays, worse functional outcomes, higher healthcare costs, and increased mortality. However, at the current time, effective prevention and treatment are not only hampered by lack of knowledge about the neuropathogenesis of POD but also by a lack of biomarkers that could predict individual risk and assess diagnosis and severity of POD.
Recent studies have focused on inflammatory markers (IL-1, IL-6, IL-8, IL-10, CRP), Alzheimer's disease-related factors (Tau, Aβ40/42), and nerve injury factors (S100β, NSE), but failed to establishing causality between these markers and POD. Furthermore, these results were contradictory. Previous study of the investigators found that the dysregulation of preoperative microRNA (miR)-146a and miR-181c in cerebrospinal fluid (CSF) and serum was associated with the development and severity of POD. Therefore, the investigators hypothesized these neurimmiRs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of POD.
Purpose: Aims to search for neuro-epigenetics biomarkers to predict and diagnose POD.
Read the detailed description
Method:
- Study design: This study is a prospective investigation that searches for neuro-epigenetics biomarkers to predict and diagnose POD.
- Inclusion criteria / Exclusion Criteria
Inclusion criteria: Eligible patients were at least 65 years old and were scheduled to have hip/knee replacement.
Exclusion Criteria:
- a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
- Patients diagnosed with malignant or benign tumors;
- Mini-Mental State Examination (MMSE) scores of 26 or less;
- American Society of Anesthesiologists (ASA) score [a global score that assesses the physical status of patients before surgery, ranging from 1 (normal health) to 5 (moribund)] greater than 3;
- a history of alcohol abuse and drug dependence;
- inability to read or severe visual or auditory deficits;
- unwillingness to comply with the protocol or procedures.
- Conditions
- Postoperative Delirium
- Being tested
- hip/knee replacement
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip/knee replacementProcedure or surgery
hip/knee replacement
| Study group | Role | What they receive |
|---|---|---|
| Delirium group | Group of patients with postoperative delirium Receives: Procedure: hip/knee replacement | |
| Non delirium group | Group of patients without postoperative delirium Receives: Procedure: hip/knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine of the participants were measured by DNA sequencing or RNA sequencing before surgery.
Measured: just before surgery
genome-specific difference between POD and non-POD patients
Compare the exon sequence in blood samples of the participants, as assessed by whole exome sequencing.
Measured: just before surgery
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Candidate cell-free DNA, cell-free RNA and exosomal RNA identified in the first outcome were quantified by PCR or RT-PCR on post operative day 1.
Measured: post operative day 1
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 3.
Measured: post operative day 3
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 7 or the day after delirium disappeared.
Measured: post operative day 7 or the day after delirium disappeared
Secondary outcomes (10)
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Measured: before surgery (from 1 week before to the day before)
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Measured: post operative day 1
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
ranging from 0 to 7 points
Measured: post operative day 1
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
ranging from -5 to +4 points
Measured: post operative day 1
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Measured: post operative day 3
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
ranging from 0 to 7 points
Measured: post operative day 3
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
ranging from -5 to +4 points
Measured: post operative day 3
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Measured: post operative day 7 or the day after delirium disappeared
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
ranging from 0 to 7 points
Measured: post operative day 7 or the day after delirium disappeared
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
ranging from -5 to +4 points
Measured: post operative day 7 or the day after delirium disappeared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start3 Nov 2021
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923243
- Sponsor's protocol ID
- HBRC202004072021014
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuro-epigenetics Biomarkers of Postoperative Delirium in Elderly Patients Undergoing Hip/Knee Replacement
- ClinicalTrials.gov ID
- NCT04923243
- Acronym / sponsor ID
- HBRC202004072021014
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 11 Jun 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.
Introduction: Postoperative delirium (POD), an acute, transient, fluctuating disturbance in attention, cognition, and level of consciousness, is a common (15-53%) postoperative complication, and it is associated with longer hospital stays, worse functional outcomes, higher healthcare costs, and increased mortality. However, at the current time, effective prevention and treatment are not only hampered by lack of knowledge about the neuropathogenesis of POD but also by a lack of biomarkers that could predict individual risk and assess diagnosis and severity of POD.
Recent studies have focused on inflammatory markers (IL-1, IL-6, IL-8, IL-10, CRP), Alzheimer's disease-related factors (Tau, Aβ40/42), and nerve injury factors (S100β, NSE), but failed to establishing causality between these markers and POD. Furthermore, these results were contradictory. Previous study of the investigators found that the dysregulation of preoperative microRNA (miR)-146a and miR-181c in cerebrospinal fluid (CSF) and serum was associated with the development and severity of POD. Therefore, the investigators hypothesized these neurimmiRs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of POD.
Purpose: Aims to search for neuro-epigenetics biomarkers to predict and diagnose POD.
Detailed description
Method:
- Study design: This study is a prospective investigation that searches for neuro-epigenetics biomarkers to predict and diagnose POD.
- Inclusion criteria / Exclusion Criteria
Inclusion criteria: Eligible patients were at least 65 years old and were scheduled to have hip/knee replacement.
Exclusion Criteria:
- a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
- Patients diagnosed with malignant or benign tumors;
- Mini-Mental State Examination (MMSE) scores of 26 or less;
- American Society of Anesthesiologists (ASA) score [a global score that assesses the physical status of patients before surgery, ranging from 1 (normal health) to 5 (moribund)] greater than 3;
- a history of alcohol abuse and drug dependence;
- inability to read or severe visual or auditory deficits;
- unwillingness to comply with the protocol or procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium group | – | Procedure: hip/knee replacementGroup of patients with postoperative delirium |
| Non delirium group | – | Procedure: hip/knee replacementGroup of patients without postoperative delirium |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients were at least 65 years old and were scheduled to have hip/knee replacement.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
- patients diagnosed with malignant or benign tumors;
- Mini-Mental State Examination (MMSE) scores of 26 or less;
- American Society of Anesthesiologists (ASA) score greater than 3;
- a history of alcohol abuse and drug dependence;
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 |
|---|---|---|
| hip/knee replacementhip/knee replacement | Procedure or surgery | Delirium group, Non delirium group |
Primary outcome
cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Time frame: just before surgery
Cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine of the participants were measured by DNA sequencing or RNA sequencing before surgery.
genome-specific difference between POD and non-POD patients
Time frame: just before surgery
Compare the exon sequence in blood samples of the participants, as assessed by whole exome sequencing.
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Time frame: post operative day 1
Candidate cell-free DNA, cell-free RNA and exosomal RNA identified in the first outcome were quantified by PCR or RT-PCR on post operative day 1.
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Time frame: post operative day 3
Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 3.
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Time frame: post operative day 7 or the day after delirium disappeared
Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 7 or the day after delirium disappeared.
10 secondary outcomes
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Time frame: before surgery (from 1 week before to the day before)
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Time frame: post operative day 1
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
Time frame: post operative day 1
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
Time frame: post operative day 1
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Time frame: post operative day 3
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
Time frame: post operative day 3
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
Time frame: post operative day 3
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Time frame: post operative day 7 or the day after delirium disappeared
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
Time frame: post operative day 7 or the day after delirium disappeared
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
Time frame: post operative day 7 or the day after delirium disappeared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
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 Zhongnan 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 0 inclusion and 7 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 1 Aug 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine (time frame: just before surgery). The study lists 5 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 1 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.