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Postoperative DeliriumNCT07239648

Postoperative Delirium in Patients Undergoing Cardiac Surgery

An observational study of Postoperative Delirium, run by Xijing Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Chong Lei, M.D.& phd contact

18629011362

crystalleichong@126.com

Zefei Zhang, M.D. contact

18811797795

zzfanita7@163.com

China1 site, 1 recruiting
  • Xijing Hospital

    Xi'an, Shaanxi

    Chong Lei, M.D.& phd, 18629011362, crystalleichong@126.com

    Zefei Zhang, M.D., 18811797795, zzfanita7@163.com

    Recruiting

Other trials in China

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.

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 groups in NCT07239648
Study groupRoleWhat they receive
delirium grouppatient developed postoperative delirium
Receives: Diagnostic Test: Serum metabolic profile
control grouppatient 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.

  1. postoperative delirium

    accessed by CAM-ICU/3D-CAM

    Measured: within 1 week after operation

Secondary outcomes (12)
  1. subtype of delirium

    accessed by CAM-ICU/3D-CAM

    Measured: within 1 week after operation

  2. severity of delirium

    accessed by CAM-ICU-7

    Measured: within 1 week after operation

  3. duration of delirium

    accessed by CAM-ICU/3D-CAM

    Measured: within 1 week after operation

  4. PSQI score 1 morth after surgery

    assessed using the Pittsburgh Sleep Quality Index

    Measured: 1 morth after surgery

  5. PSQI score 6 morth after surgery

    assessed using the Pittsburgh Sleep Quality Index

    Measured: 6 morth after surgery

  6. PSQI score 1 year after surgery

    assessed using the Pittsburgh Sleep Quality Index

    Measured: 1 year after surgery

  7. T-Moca 1 morth after surgery

    assessed using the T-Moca

    Measured: 1 morth after surgery

  8. T-Moca score 6 morth after surgery

    assessed using the T-Moca

    Measured: 6 morth after surgery

  9. T-Moca score 1 year after surgery

    assessed using the T-Moca

    Measured: 1 year after surgery

  10. pain 1 morth after surgery

    assessed using the NRS score

    Measured: 1 morth after surgery

  11. pain 6 morth after surgery

    assessed using the NRS score

    Measured: 6 morth after surgery

  12. 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.

  1. First posted20 Nov 2025
  2. Study start31 Oct 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

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.

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