Postoperative Delirium (POD)DeliriumNCT06901479
The Study of Postoperative Delirium and Glymphatic System Function in Cardiac Surgery
An observational study of Postoperative Delirium (POD), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Postoperative delirium after cardiac surgery is an acute cerebral dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances. It manifests clinically as acute onset, severe neurocognitive impairment, and periodic fluctuating progression, and is one of the most common… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Blood was drawn for proteomics testing and Magnetic Resonance Imaging.
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age over 60 years, undergoing cardiac surgery.
Who may be able to join
- Undergoing elective cardiac surgery with cardiopulmonary bypass (such as coronary artery bypass grafting, bioprosthetic valve replacement, valve repair, congenital heart surgery, etc.);
- Age ≥ 60 years.
Who cannot join
- Aortic dissection and other surgeries involving major blood vessels;
- A history of mental illness with related medication use; preoperative Mini-Mental State Examination (MMSE) score < 27; preoperative delirium;
- A history of neurosurgery or traumatic brain injury; if a focal brain lesion larger than 3 cm occurs during the study, the data will be excluded from subsequent analyses;
- Hearing and language impairments that affect communication;
- Contraindications to MRI (e.g., presence of metal implants in the body, including prosthetic valve replacement, internal fixation plates after fracture surgery, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative delirium after cardiac surgery is an acute cerebral dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances. It manifests clinically as acute onset, severe neurocognitive impairment, and periodic fluctuating progression, and is one of the most common complications after major cardiac and vascular surgery. It typically occurs within one week after surgery, with a peak incidence at 24 hours postoperatively. Due to differences in the basic characteristics of study populations and assessment tools, the reported incidence of postoperative delirium after cardiac surgery varies significantly, ranging from 14% to 50%. Postoperative delirium not only prolongs patients' ICU and hospital stays, increases medical costs, and raises short-term and long-term mortality rates, but is also closely associated with long-term cognitive impairment, dementia, and a decline in activities of daily living. The pathophysiology of delirium is complex and may be caused by a combination of multiple factors, including microembolism, ischemia-reperfusion injury, and systemic inflammatory response. Since the mechanisms underlying delirium are not yet fully understood, effective treatments are currently lacking. Postoperative delirium after cardiac surgery is a significant clinical challenge for medical teams.
The brain is distinct from other organs, as the tight junctions of the blood-brain barrier isolate the exchange between the brain, cerebrospinal fluid, blood, and extracellular fluid. For a long time, it was believed that the brain lacks a lymphatic system, and the extracellular fluid in brain tissue was considered stagnant. The lack of fluid flow can lead to the accumulation of protein waste, which is very detrimental to brain health. The glymphatic system is a major update in the anatomical knowledge of the central nervous system in recent years. It is a highly organized fluid transport system within the human brain, with the primary function of promoting convective exchange between the interstitial fluid of the central nervous system and cerebrospinal fluid. The main physiological function of the glymphatic system is to clear metabolic waste and large-molecule solutes, thereby maintaining central homeostasis; it also acts as a communicator between the brain and peripheral immunity, ensuring that the central nervous system is not overlooked by the immune system. Additionally, the glymphatic system helps deliver nutrients to the brain, such as glucose, lactate, and amino acids. Dysfunction of the glymphatic system is associated with various neurological diseases, such as Alzheimer's disease and Parkinson's disease, and related research has become a frontier and hotspot in the field of neuroscience.
Read more
Dysfunction of the glymphatic system leads to the accumulation of β-amyloid and tau proteins in the brain, which cannot be cleared, and is one of the pathogenic mechanisms of Alzheimer's disease. There is a strong bidirectional association between Alzheimer's disease and delirium. Patients with Alzheimer's disease-related dementia are 2.5 to 4.7 times more likely to experience delirium, and the incidence of newly diagnosed Alzheimer's disease-related dementia in patients with delirium increases by 12.5 times. However, the underlying mechanisms of postoperative delirium remain unclear, which has motivated our investigation into the causal relationship between the glymphatic system and postoperative delirium. From a theoretical perspective, chronic dysfunction of the glymphatic system signifies brain vulnerability and a higher incidence of neurological diseases. If subjected to surgical stress, sudden dysfunction may represent acute glymphatic system insufficiency. With the rapid development of clinical imaging tools, functional MRI is a non-invasive method for assessing glymphatic system function, bringing possibilities to clinical research.
Therefore, this study aims to explore the association between postoperative delirium after cardiac surgery and the glymphatic system, in order to deepen the understanding of glymphatic system function and investigate the mechanisms of postoperative delirium after cardiac surgery, and to provide ideas for new interventions for postoperative delirium after cardiac surgery.
- Conditions
- Postoperative Delirium (POD)
- Being tested
- Blood was drawn for proteomics testing and Magnetic Resonance Imaging.
- Keywords
- analysis along the perivascular space, diffusion tensor imaging, glymphatic system, Postoperative delirium, cardiac surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood was drawn for proteomics testing and Magnetic Resonance Imaging.Other
The function of the glymphatic system was assessed by MRI before the surgery. Blood was drawn before the surgery. Delirium was assessed on postoperative days 1 to 5. Blood was drawn on the second day after surgery. The function of the glymphatic system was assessed again by MRI on the fifth day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| The cardiac surgery postoperative delirium group | 1. Patients who met the inclusion and exclusion criteria underwent MRI assessment of the glymphatic system function before cardiac surgery after signing the informed consent form.
2. The patients underwent routine cardiac surgery.
3. Blood was drawn before the surgery.
4. Delirium was assessed on postoperative days 1 to 5.
5. Blood was drawn on the second day after surgery, and MRI assessment of the glymphatic system function was performed again on the fifth day after surgery. Receives: Other: Blood was drawn for proteomics testing and Magnetic Resonance Imaging. | |
| The cardiac surgery postoperative non-delirium group | 1. Patients who met the inclusion and exclusion criteria underwent MRI assessment of the glymphatic system function before cardiac surgery after signing the informed consent form.
2. The patients underwent routine cardiac surgery.
3. Blood was drawn before the surgery.
4. Delirium was assessed on postoperative days 1 to 5.
5. Blood was drawn on the second day after surgery.
6. Patients who did not develop postoperative delirium were selected as the control group, matched for age, BMI, and duration of surgery, and underwent MRI assessment of the glymphatic system function again on the fifth day after surgery. Receives: Other: Blood was drawn for proteomics testing and Magnetic Resonance Imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Using the 3-Minute Diagnostic Assessment for Delirium
Measured: Postoperative delirium was assessed on postoperative days 1 to 5
Secondary outcomes (2)
Analysis along the perivascular space (ALPS)
MRI indicators for assessing glymphatic system function
Measured: 1、Before surgery;2、On the fifth day after surgery
Blood was drawn for proteomics testing
Measured: 1、Before surgery; 2、On the fifth day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901479
- Sponsor's protocol ID
- KY20250225-07
- Acronym
- Delirium
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Postoperative Delirium and Glymphatic System Function in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06901479
- Acronym / sponsor ID
- Delirium / KY20250225-07
- Conditions
- Postoperative Delirium (POD)
- Keywords
- analysis along the perivascular space, diffusion tensor imaging, glymphatic system, Postoperative delirium, cardiac surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Mar 2025 (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.
Postoperative delirium after cardiac surgery is an acute cerebral dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances. It manifests clinically as acute onset, severe neurocognitive impairment, and periodic fluctuating progression, and is one of the most common complications after major cardiac and vascular surgery. It typically occurs within one week after surgery, with a peak incidence at 24 hours postoperatively. Due to differences in the basic characteristics of study populations and assessment tools, the reported incidence of postoperative delirium after cardiac surgery varies significantly, ranging from 14% to 50%. Postoperative delirium not only prolongs patients' ICU and hospital stays, increases medical costs, and raises short-term and long-term mortality rates, but is also closely associated with long-term cognitive impairment, dementia, and a decline in activities of daily living. The pathophysiology of delirium is complex and may be caused by a combination of multiple factors, including microembolism, ischemia-reperfusion injury, and systemic inflammatory response. Since the mechanisms underlying delirium are not yet fully understood, effective treatments are currently lacking. Postoperative delirium after cardiac surgery is a significant clinical challenge for medical teams.
The brain is distinct from other organs, as the tight junctions of the blood-brain barrier isolate the exchange between the brain, cerebrospinal fluid, blood, and extracellular fluid. For a long time, it was believed that the brain lacks a lymphatic system, and the extracellular fluid in brain tissue was considered stagnant. The lack of fluid flow can lead to the accumulation of protein waste, which is very detrimental to brain health. The glymphatic system is a major update in the anatomical knowledge of the central nervous system in recent years. It is a highly organized fluid transport system within the human brain, with the primary function of promoting convective exchange between the interstitial fluid of the central nervous system and cerebrospinal fluid. The main physiological function of the glymphatic system is to clear metabolic waste and large-molecule solutes, thereby maintaining central homeostasis; it also acts as a communicator between the brain and peripheral immunity, ensuring that the central nervous system is not overlooked by the immune system. Additionally, the glymphatic system helps deliver nutrients to the brain, such as glucose, lactate, and amino acids. Dysfunction of the glymphatic system is associated with various neurological diseases, such as Alzheimer's disease and Parkinson's disease, and related research has become a frontier and hotspot in the field of neuroscience.
Dysfunction of the glymphatic system leads to the accumulation of β-amyloid and tau proteins in the brain, which cannot be cleared, and is one of the pathogenic mechanisms of Alzheimer's disease. There is a strong bidirectional association between Alzheimer's disease and delirium. Patients with Alzheimer's disease-related dementia are 2.5 to 4.7 times more likely to experience delirium, and the incidence of newly diagnosed Alzheimer's disease-related dementia in patients with delirium increases by 12.5 times. However, the underlying mechanisms of postoperative delirium remain unclear, which has motivated our investigation into the causal relationship between the glymphatic system and postoperative delirium. From a theoretical perspective, chronic dysfunction of the glymphatic system signifies brain vulnerability and a higher incidence of neurological diseases. If subjected to surgical stress, sudden dysfunction may represent acute glymphatic system insufficiency. With the rapid development of clinical imaging tools, functional MRI is a non-invasive method for assessing glymphatic system function, bringing possibilities to clinical research.
Therefore, this study aims to explore the association between postoperative delirium after cardiac surgery and the glymphatic system, in order to deepen the understanding of glymphatic system function and investigate the mechanisms of postoperative delirium after cardiac surgery, and to provide ideas for new interventions for postoperative delirium after cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The cardiac surgery postoperative delirium group | – | Other: Blood was drawn for proteomics testing and Magnetic Resonance Imaging.1. Patients who met the inclusion and exclusion criteria underwent MRI assessment of the glymphatic system function before cardiac surgery after signing the informed consent form. 2. The patients underwent routine cardiac surgery. 3. Blood was drawn before the surgery. 4. Delirium was assessed on postoperative days 1 to 5. 5. Blood was drawn on the second day after surgery, and MRI assessment of the glymphatic system function was performed again on the fifth day after surgery. |
| The cardiac surgery postoperative non-delirium group | – | Other: Blood was drawn for proteomics testing and Magnetic Resonance Imaging.1. Patients who met the inclusion and exclusion criteria underwent MRI assessment of the glymphatic system function before cardiac surgery after signing the informed consent form. 2. The patients underwent routine cardiac surgery. 3. Blood was drawn before the surgery. 4. Delirium was assessed on postoperative days 1 to 5. 5. Blood was drawn on the second day after surgery. 6. Patients who did not develop postoperative delirium were selected as the control group, matched for age, BMI, and duration of surgery, and underwent MRI assessment of the glymphatic system function again on the fifth day after surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age over 60 years, undergoing cardiac surgery.
Key inclusion criteria (2 listed)
- Undergoing elective cardiac surgery with cardiopulmonary bypass (such as coronary artery bypass grafting, bioprosthetic valve replacement, valve repair, congenital heart surgery, etc.);
- Age ≥ 60 years.
Key exclusion criteria (5 listed)
- Aortic dissection and other surgeries involving major blood vessels;
- A history of mental illness with related medication use; preoperative Mini-Mental State Examination (MMSE) score < 27; preoperative delirium;
- A history of neurosurgery or traumatic brain injury; if a focal brain lesion larger than 3 cm occurs during the study, the data will be excluded from subsequent analyses;
- Hearing and language impairments that affect communication;
- Contraindications to MRI (e.g., presence of metal implants in the body, including prosthetic valve replacement, internal fixation plates after fracture surgery, etc.).
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 |
|---|---|---|
| Blood was drawn for proteomics testing and Magnetic Resonance Imaging.The function of the glymphatic system was assessed by MRI before the surgery. Blood was drawn before the surgery. Delirium was assessed on postoperative days 1 to 5. Blood was drawn on the second day after surgery. The function of the glymphatic system was assessed again by MRI on the fifth day after surgery. | Other | The cardiac surgery postoperative delirium group, The cardiac surgery postoperative non-delirium group |
Primary outcome
Postoperative delirium
Time frame: Postoperative delirium was assessed on postoperative days 1 to 5
Using the 3-Minute Diagnostic Assessment for Delirium
2 secondary outcomes
Analysis along the perivascular space (ALPS)
Time frame: 1、Before surgery;2、On the fifth day after surgery
Blood was drawn for proteomics testing
Time frame: 1、Before surgery; 2、On the fifth day after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (POD), run by Nanjing First Hospital, Nanjing 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: Postoperative delirium was assessed on postoperative days 1 to 5). 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 30 Mar 2025.