Postoperative DeliriumNCT07239648
Postoperative Delirium in Patients Undergoing Cardiac Surgery
An observational study of Postoperative Delirium, run by Xijing Hospital at 1 site in China.
Trial summary
Establish a follow-up database for postoperative delirium in cardiac surgery patients, adopt a bidirectional cohort design to simultaneously analyze the associations between "preoperative exposure factors and postoperative delirium incidence" and "postoperative delirium and long-term adverse outcomes", and clarify the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Serum metabolic profile
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2025to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective cardiac surgery
Who may be able to join
- 18 years old and above
- Patients undergoing elective cardiac surgery
Who cannot join
- Organ transplantation surgery
- Pregnant patients
- Diagnosed with dementia or mental illness (such as schizophrenia) before surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi
Chong Lei, M.D.& phd, 18629011362, crystalleichong@126.com
Zefei Zhang, M.D., 18811797795, zzfanita7@163.com
About this study
Official title: A Real-World Single-Center Bidirectional Cohort Study on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Establish a follow-up database for postoperative delirium in cardiac surgery patients, adopt a bidirectional cohort design to simultaneously analyze the associations between "preoperative exposure factors and postoperative delirium incidence" and "postoperative delirium and long-term adverse outcomes", and clarify the predictive factors and prognostic impacts of postoperative delirium.
Read the detailed description
Due to special reasons such as severe surgical trauma, high surgical stress, cardiopulmonary bypass, and the need to be transferred to the Cardiothoracic and Vascular Intensive Care Unit after surgery1-3, the incidence of postoperative delirium (POD) following cardiac and great vessel surgery is as high as 26%~52%4-6. POD refers to an acute neurofunctional disorder that occurs after surgery, mainly characterized by confusion and decreased ability of spatial and temporal orientation7-12. Relevant studies have confirmed that POD significantly prolongs the duration of mechanical ventilation and ICU stay of patients, increases the incidence of complications, and is closely associated with long-term cognitive decline and increased long-term mortality13, which has become a key issue affecting the prognosis of surgical patients. The 2024 Update of the Evidence-Based and Consensus Guidelines on Postoperative Delirium in Adult Patients by the European Society of Anaesthesiology and Intensive Care Medicine clearly points out that POD seriously affects the outcome of the disease, which can lead to prolonged hospital stay, increased mortality, further impairment of physical and cognitive functions, and increased medical costs of patients, so it should attract the attention of clinical medical workers and researchers14. However, it is more noteworthy that although the incidence of delirium after cardiac surgery is high, there is no ideal treatment method. At present, the guidelines only recommend the use of low-dose haloperidol or dexmedetomidine for symptomatic treatment of POD, and the quality of evidence and strength of recommendation are both weak15. At the same time, the guidelines emphasize that more in-depth research on the pathogenesis, existing risk factors, development and treatment of POD should be encouraged16. The guidelines specifically propose that "early identification of patients at high risk of POD is required", emphasizing the important value of early intervention in improving the prognosis of patients. Against this background, clarifying the predictive factors of POD and reducing its incidence have become an urgent and important clinical task.
In terms of research progress, certain breakthroughs have been made in the exploration of POD risk identification and prognosis prediction: many previous studies published in Anesthesiology, BJA and other journals have pointed out that advanced age, male gender, preoperative cognitive impairment, sleep deprivation, frailty and other factors may be risk factors for POD17-20, and some studies have also attempted to construct simple risk assessment models based on these factors21,22. However, on the whole, the current research still has significant limitations, which restrict the repeated verification and further exploration of the research results. On the one hand, the correlation of risk factors is mostly verified by single-center and small-sample studies, lacking the support of large-sample and long-term follow-up data, resulting in fragmented research evidence, which makes it difficult to fully reveal the pathogenesis and prognostic impact chain of postoperative delirium; on the other hand, the lack of standardized norms for research data collection leads to the difficulty in repeated verification of research results, which has also become a core problem restricting the progress of risk identification and prognosis prediction research. The specific reasons mainly include two aspects: ① Ununified assessment tools: There are more than 10 kinds of POD diagnostic tools, including CAM-ICU, ICDSC, DRS-R-98, etc. Different studies adopt different tools, resulting in a difference in incidence rate of up to 2-3 times, making it impossible to compare research results horizontally17-22; ② Scattered data storage: POD-related data (preoperative cognitive assessment, intraoperative monitoring records, postoperative delirium diagnosis, long-term follow-up) are scattered in the hospital's HIS system, LIS system, nursing record system and outpatient follow-up system, lacking integration in a unified database, leading to low efficiency of research data extraction and easy omission of key information23-25.
In response to the above research gaps and clinical needs, this study innovatively adopts a bidirectional cohort study design. By integrating two research methods, namely "retrospective tracing of postoperative information of past cardiac surgery patients" and "prospective collection of postoperative data of cardiac surgery patients", it realizes the construction of a large-sample postoperative follow-up database, thereby establishing a full-chain analysis framework of "exposure - delirium - outcome", and fundamentally solving the core problems of existing studies: At the level of diagnostic tools, based on clinical evidence-based evidence, this study will uniformly adopt the internationally recognized CAM-ICU/3D CAM assessment tools to ensure the consistency of POD diagnostic criteria, eliminate the statistical deviation of incidence rate caused by tool differences, and realize the horizontal comparability of research data; At the level of data integration, this study will cooperate with the hospital's information department to construct a special integrated database for POD in cardiac surgery, systematically connect data from multiple systems such as HIS, LIS, nursing records and outpatient follow-up, and conduct structured collation according to the time dimension of "preoperative - intraoperative - postoperative - long-term" to solve the problem of scattered data storage and improve the efficiency and integrity of data extraction; At the level of long-term follow-up data support, relying on the follow-up management platform of the anesthesiology department, this study will establish a large-sample long-term follow-up cohort to realize the full-cycle data collection from preoperative cognitive baseline to long-term postoperative prognosis, fill the gap of fragmented evidence in existing studies, and fully reveal the pathogenesis and prognostic impact path of POD.
In summary, this study can not only fill the gaps in current POD research in terms of tool unification, data integration and long-term follow-up through standardized design and innovative methods, but also provide direct scientific basis for the clinical formulation of POD risk prediction models and prevention and control strategies. It has important academic and practical value, and is of great significance for promoting the improvement of prognosis of patients in the field of cardiac and great vessel surgery.
- Conditions
- Postoperative Delirium
- Being tested
- Serum metabolic profile
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum metabolic profileDiagnostic test
Venous serum samples are analyzed for serum metabolic profiles or other test
| Study group | Role | What they receive |
|---|---|---|
| delirium group | patient developed postoperative delirium Receives: Diagnostic Test: Serum metabolic profile | |
| control group | patient don't develop postoperative delirium Receives: Diagnostic Test: Serum metabolic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
accessed by CAM-ICU/3D-CAM
Measured: within 1 week after operation
Secondary outcomes (12)
subtype of delirium
accessed by CAM-ICU/3D-CAM
Measured: within 1 week after operation
severity of delirium
accessed by CAM-ICU-7
Measured: within 1 week after operation
duration of delirium
accessed by CAM-ICU/3D-CAM
Measured: within 1 week after operation
PSQI score 1 morth after surgery
assessed using the Pittsburgh Sleep Quality Index
Measured: 1 morth after surgery
PSQI score 6 morth after surgery
assessed using the Pittsburgh Sleep Quality Index
Measured: 6 morth after surgery
PSQI score 1 year after surgery
assessed using the Pittsburgh Sleep Quality Index
Measured: 1 year after surgery
T-Moca 1 morth after surgery
assessed using the T-Moca
Measured: 1 morth after surgery
T-Moca score 6 morth after surgery
assessed using the T-Moca
Measured: 6 morth after surgery
T-Moca score 1 year after surgery
assessed using the T-Moca
Measured: 1 year after surgery
pain 1 morth after surgery
assessed using the NRS score
Measured: 1 morth after surgery
pain 6 morth after surgery
assessed using the NRS score
Measured: 6 morth after surgery
pain 1 year after surgery
assessed using the NRS score
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start31 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by Xijing HospitalThe 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
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239648
- Sponsor's protocol ID
- KY20252528
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Single-Center Bidirectional Cohort Study on Postoperative Delirium in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07239648
- Acronym / sponsor ID
- KY20252528
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Nov 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.
Establish a follow-up database for postoperative delirium in cardiac surgery patients, adopt a bidirectional cohort design to simultaneously analyze the associations between "preoperative exposure factors and postoperative delirium incidence" and "postoperative delirium and long-term adverse outcomes", and clarify the predictive factors and prognostic impacts of postoperative delirium.
Detailed description
Due to special reasons such as severe surgical trauma, high surgical stress, cardiopulmonary bypass, and the need to be transferred to the Cardiothoracic and Vascular Intensive Care Unit after surgery1-3, the incidence of postoperative delirium (POD) following cardiac and great vessel surgery is as high as 26%~52%4-6. POD refers to an acute neurofunctional disorder that occurs after surgery, mainly characterized by confusion and decreased ability of spatial and temporal orientation7-12. Relevant studies have confirmed that POD significantly prolongs the duration of mechanical ventilation and ICU stay of patients, increases the incidence of complications, and is closely associated with long-term cognitive decline and increased long-term mortality13, which has become a key issue affecting the prognosis of surgical patients. The 2024 Update of the Evidence-Based and Consensus Guidelines on Postoperative Delirium in Adult Patients by the European Society of Anaesthesiology and Intensive Care Medicine clearly points out that POD seriously affects the outcome of the disease, which can lead to prolonged hospital stay, increased mortality, further impairment of physical and cognitive functions, and increased medical costs of patients, so it should attract the attention of clinical medical workers and researchers14. However, it is more noteworthy that although the incidence of delirium after cardiac surgery is high, there is no ideal treatment method. At present, the guidelines only recommend the use of low-dose haloperidol or dexmedetomidine for symptomatic treatment of POD, and the quality of evidence and strength of recommendation are both weak15. At the same time, the guidelines emphasize that more in-depth research on the pathogenesis, existing risk factors, development and treatment of POD should be encouraged16. The guidelines specifically propose that "early identification of patients at high risk of POD is required", emphasizing the important value of early intervention in improving the prognosis of patients. Against this background, clarifying the predictive factors of POD and reducing its incidence have become an urgent and important clinical task.
In terms of research progress, certain breakthroughs have been made in the exploration of POD risk identification and prognosis prediction: many previous studies published in Anesthesiology, BJA and other journals have pointed out that advanced age, male gender, preoperative cognitive impairment, sleep deprivation, frailty and other factors may be risk factors for POD17-20, and some studies have also attempted to construct simple risk assessment models based on these factors21,22. However, on the whole, the current research still has significant limitations, which restrict the repeated verification and further exploration of the research results. On the one hand, the correlation of risk factors is mostly verified by single-center and small-sample studies, lacking the support of large-sample and long-term follow-up data, resulting in fragmented research evidence, which makes it difficult to fully reveal the pathogenesis and prognostic impact chain of postoperative delirium; on the other hand, the lack of standardized norms for research data collection leads to the difficulty in repeated verification of research results, which has also become a core problem restricting the progress of risk identification and prognosis prediction research. The specific reasons mainly include two aspects: ① Ununified assessment tools: There are more than 10 kinds of POD diagnostic tools, including CAM-ICU, ICDSC, DRS-R-98, etc. Different studies adopt different tools, resulting in a difference in incidence rate of up to 2-3 times, making it impossible to compare research results horizontally17-22; ② Scattered data storage: POD-related data (preoperative cognitive assessment, intraoperative monitoring records, postoperative delirium diagnosis, long-term follow-up) are scattered in the hospital's HIS system, LIS system, nursing record system and outpatient follow-up system, lacking integration in a unified database, leading to low efficiency of research data extraction and easy omission of key information23-25.
In response to the above research gaps and clinical needs, this study innovatively adopts a bidirectional cohort study design. By integrating two research methods, namely "retrospective tracing of postoperative information of past cardiac surgery patients" and "prospective collection of postoperative data of cardiac surgery patients", it realizes the construction of a large-sample postoperative follow-up database, thereby establishing a full-chain analysis framework of "exposure - delirium - outcome", and fundamentally solving the core problems of existing studies: At the level of diagnostic tools, based on clinical evidence-based evidence, this study will uniformly adopt the internationally recognized CAM-ICU/3D CAM assessment tools to ensure the consistency of POD diagnostic criteria, eliminate the statistical deviation of incidence rate caused by tool differences, and realize the horizontal comparability of research data; At the level of data integration, this study will cooperate with the hospital's information department to construct a special integrated database for POD in cardiac surgery, systematically connect data from multiple systems such as HIS, LIS, nursing records and outpatient follow-up, and conduct structured collation according to the time dimension of "preoperative - intraoperative - postoperative - long-term" to solve the problem of scattered data storage and improve the efficiency and integrity of data extraction; At the level of long-term follow-up data support, relying on the follow-up management platform of the anesthesiology department, this study will establish a large-sample long-term follow-up cohort to realize the full-cycle data collection from preoperative cognitive baseline to long-term postoperative prognosis, fill the gap of fragmented evidence in existing studies, and fully reveal the pathogenesis and prognostic impact path of POD.
In summary, this study can not only fill the gaps in current POD research in terms of tool unification, data integration and long-term follow-up through standardized design and innovative methods, but also provide direct scientific basis for the clinical formulation of POD risk prediction models and prevention and control strategies. It has important academic and practical value, and is of great significance for promoting the improvement of prognosis of patients in the field of cardiac and great vessel surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium group | – | Diagnostic Test: Serum metabolic profilepatient developed postoperative delirium |
| control group | – | Diagnostic Test: Serum metabolic profilepatient don't develop postoperative delirium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery
Key inclusion criteria (2 listed)
- 18 years old and above
- Patients undergoing elective cardiac surgery
Key exclusion criteria (3 listed)
- Organ transplantation surgery
- Pregnant patients
- Diagnosed with dementia or mental illness (such as schizophrenia) before surgery
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 |
|---|---|---|
| Serum metabolic profileVenous serum samples are analyzed for serum metabolic profiles or other test | Diagnostic test | control group, delirium group |
Primary outcome
postoperative delirium
Time frame: within 1 week after operation
accessed by CAM-ICU/3D-CAM
12 secondary outcomes
subtype of delirium
Time frame: within 1 week after operation
severity of delirium
Time frame: within 1 week after operation
duration of delirium
Time frame: within 1 week after operation
PSQI score 1 morth after surgery
Time frame: 1 morth after surgery
PSQI score 6 morth after surgery
Time frame: 6 morth after surgery
PSQI score 1 year after surgery
Time frame: 1 year after surgery
T-Moca 1 morth after surgery
Time frame: 1 morth after surgery
T-Moca score 6 morth after surgery
Time frame: 6 morth after surgery
T-Moca score 1 year after surgery
Time frame: 1 year after surgery
pain 1 morth after surgery
Time frame: 1 morth after surgery
pain 6 morth after surgery
Time frame: 6 morth after surgery
pain 1 year after surgery
Time frame: 1 year 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 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Xijing 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 2 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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?
Contact Chong Lei, M.D.& phd (18629011362, crystalleichong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium (time frame: within 1 week after operation). 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 4 Aug 2026.