Postoperative DeliriumNCT07759297
Intraoperative Dexmedetomidine Use, MMP-8, and Postoperative Delirium After Cardiac Surgery With Cardiopulmonary Bypass
An observational study of Postoperative Delirium, run by Shusheng Li at 1 site in China.
Trial summary
This observational study evaluated the association between intraoperative dexmedetomidine use and postoperative delirium (POD) in adults undergoing cardiac surgery with cardiopulmonary bypass (CPB). The study included two linked clinical components. 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?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 5,688 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 15 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults aged 18 years or older who underwent cardiac surgery with cardiopulmonary bypass. The retrospective cohort included eligible patients treated at three campuses of Tongji Hospital between January 2015 and December 2022. The prospective biomarker cohort consisted of participants enrolled between April 2023 and September 2024 for whom archived perioperative plasma samples and linked clinical data were available.
Who may be able to join
- Adults aged 18 years or older.
- Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
- For the retrospective cohort, eligible patients undergoing cardiac surgery with CPB at the three participating campuses of Tongji Hospital between January 2015 and December 2022.
- For the prospective biomarker cohort, eligible participants enrolled between April 2023 and September 2024 with archived plasma samples collected preoperatively, at the end of surgery, and 24 h postoperatively, together with linked clinical data.
Who cannot join
- Conditions precluding dexmedetomidine use, including second- or third-degree atrioventricular block without a pacemaker, uncontrolled hypotension, acute cerebrovascular disease, or known hypersensitivity to dexmedetomidine.
- Severe neurological or psychiatric disorders, including a history of treatment for severe mental illness.
- Inability to communicate effectively because of severe hearing, visual, or speech impairments.
- Pregnancy or breastfeeding.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Association of Intraoperative Dexmedetomidine Use and Perioperative Plasma MMP-8 Dynamics With Postoperative Delirium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
This observational study evaluated the association between intraoperative dexmedetomidine use and postoperative delirium (POD) in adults undergoing cardiac surgery with cardiopulmonary bypass (CPB). The study included two linked clinical components. First, routinely collected clinical data from patients undergoing cardiac surgery with CPB at three campuses of Tongji Hospital between January 2015 and December 2022 were analyzed to evaluate the dexmedetomidine-POD association. Second, perioperative plasma samples and clinical data from a prospective observational cohort enrolled between April 2023 and September 2024 were used to characterize perioperative matrix metalloproteinase-8 (MMP-8) dynamics and their associations with intraoperative dexmedetomidine use and POD. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol.
Read the detailed description
This hospital-based observational study comprised two linked clinical components designed to evaluate the association between intraoperative dexmedetomidine use and postoperative delirium (POD) after cardiac surgery with cardiopulmonary bypass (CPB) and to explore the clinical relevance of perioperative matrix metalloproteinase-8 (MMP-8) responses.
The first component was a retrospective multicampus cohort study using routinely collected clinical data from three campuses of Tongji Hospital. Adult patients undergoing cardiac surgery with CPB between January 2015 and December 2022 were screened according to predefined eligibility criteria. The primary exposure was intraoperative dexmedetomidine administration by continuous intravenous infusion, ascertained from anesthesia records. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol. The primary outcome was POD occurring within 7 days after surgery. Documented POD diagnoses were accepted as confirmed events; when no explicit diagnosis was documented, postoperative medical and nursing records were retrospectively reviewed by trained anesthesiologists and intensivists blinded to intraoperative dexmedetomidine exposure. Secondary outcomes included in-hospital mortality and hospital length of stay. Multivariable regression, propensity score matching, subgroup and interaction analyses, and E-value analysis were used to evaluate the robustness of the dexmedetomidine-POD association.
The second component used archived plasma samples and linked clinical data from a previously established prospective observational cohort of adults undergoing cardiac surgery with CPB who were enrolled between April 2023 and September 2024. In the original cohort, intraoperative dexmedetomidine use was determined by the treating anesthesiologist and was not influenced by the study investigators. POD within 7 days after surgery was prospectively assessed, and participants were followed until hospital discharge. Plasma samples had been collected preoperatively, at the end of surgery, and 24 h postoperatively and stored for subsequent analyses. The original prospective cohort enrollment and perioperative biospecimen collection were approved by the Medical Ethics Committee of Tongji Hospital under Approval No. TJ-IRB20231224. The current study, including secondary analyses of archived clinical data and plasma samples, was subsequently approved under Approval No. TJ-IRB202603077. Archived plasma samples were analyzed for MMP-8, and perioperative MMP-8 levels and changes were evaluated in relation to dexmedetomidine exposure and POD. Additional analyses assessed the discriminatory value of perioperative MMP-8 measures for POD and their potential statistical mediating role in the association between intraoperative dexmedetomidine use and POD.
- Conditions
- Postoperative Delirium
- Being tested
- Dexmedetomidine
- Keywords
- Cardiac Surgery, Dexmedetomidine, Cardiopulmonary Bypass, Matrix Metalloproteinase 8, MMP-8
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intraoperative dexmedetomidine administration during cardiac surgery with cardiopulmonary bypass was an observed clinical exposure. The decision to administer dexmedetomidine, including its dose, timing, and duration, was made by the treating anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned or standardized by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort - Dexmedetomidine Exposed | Patients in the retrospective multicampus cohort who underwent cardiac surgery with cardiopulmonary bypass between January 2015 and December 2022 and received intraoperative dexmedetomidine by continuous intravenous infusion as part of routine anesthetic care. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and was not assigned by the study protocol. Receives: Drug: Dexmedetomidine | |
| Retrospective Cohort - No Dexmedetomidine Exposure | Patients in the retrospective multicampus cohort who underwent cardiac surgery with cardiopulmonary bypass between January 2015 and December 2022 and did not receive intraoperative dexmedetomidine. | |
| Prospective Cohort - Dexmedetomidine Exposed | Participants in the previously established prospective observational cohort who underwent cardiac surgery with cardiopulmonary bypass between April 2023 and September 2024 and received intraoperative dexmedetomidine as part of routine anesthetic care. Dexmedetomidine use was determined by the treating anesthesiologist and was not influenced by the study investigators. Archived perioperative plasma samples from these participants were used for the present MMP-8 analyses. Receives: Drug: Dexmedetomidine | |
| Prospective Cohort - No Dexmedetomidine Exposure | Participants in the previously established prospective observational cohort who underwent cardiac surgery with cardiopulmonary bypass between April 2023 and September 2024 and did not receive intraoperative dexmedetomidine. Archived perioperative plasma samples from these participants were used for the present MMP-8 analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium
The number and proportion of participants who experienced at least one episode of postoperative delirium within 7 days after surgery. In the retrospective cohort, POD was ascertained from postoperative medical and nursing records using adapted DSM-5 criteria, with blinded review when no explicit diagnosis was documented. In the prospective cohort, POD was assessed prospectively by trained anesthesiologists and intensivists using the CAM-ICU.
Measured: From the end of surgery through postoperative day 7
Secondary outcomes (2)
Hospital Length of Stay
The number of calendar days from hospital admission to hospital discharge during the index hospitalization.
Measured: From hospital admission through hospital discharge during the index hospitalization, an average of approximately 3 weeks.
In-Hospital All-Cause Mortality
The number and proportion of participants who died from any cause during the index hospitalization after cardiac surgery.
Measured: From the end of surgery until death or hospital discharge, whichever occurred first, an average of approximately 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Apr 2023
- Primary completion2 Oct 2024
- Study completion15 Oct 2024
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
- Other
- Enrolment
- 5,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shusheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shusheng Li, Tongji Hospital
- Investigators
- Qin Zhang, Principal investigator, Tongj Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759297
- Sponsor's protocol ID
- TJ-IRB202603077
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, together with relevant analytic code, may be made available upon reasonable request to the corresponding author, subject to review by the study team and compliance with institutional ethics, data governance, and participant privacy requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intraoperative Dexmedetomidine Use and Perioperative Plasma MMP-8 Dynamics With Postoperative Delirium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07759297
- Acronym / sponsor ID
- TJ-IRB202603077
- Conditions
- Postoperative Delirium
- Keywords
- Cardiac Surgery, Dexmedetomidine, Cardiopulmonary Bypass, Matrix Metalloproteinase 8, MMP-8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,688 participants (actual)
- Lead sponsor
- Shusheng LiUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 12 Aug 2026 (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.
This observational study evaluated the association between intraoperative dexmedetomidine use and postoperative delirium (POD) in adults undergoing cardiac surgery with cardiopulmonary bypass (CPB). The study included two linked clinical components. First, routinely collected clinical data from patients undergoing cardiac surgery with CPB at three campuses of Tongji Hospital between January 2015 and December 2022 were analyzed to evaluate the dexmedetomidine-POD association. Second, perioperative plasma samples and clinical data from a prospective observational cohort enrolled between April 2023 and September 2024 were used to characterize perioperative matrix metalloproteinase-8 (MMP-8) dynamics and their associations with intraoperative dexmedetomidine use and POD. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol.
Detailed description
This hospital-based observational study comprised two linked clinical components designed to evaluate the association between intraoperative dexmedetomidine use and postoperative delirium (POD) after cardiac surgery with cardiopulmonary bypass (CPB) and to explore the clinical relevance of perioperative matrix metalloproteinase-8 (MMP-8) responses.
The first component was a retrospective multicampus cohort study using routinely collected clinical data from three campuses of Tongji Hospital. Adult patients undergoing cardiac surgery with CPB between January 2015 and December 2022 were screened according to predefined eligibility criteria. The primary exposure was intraoperative dexmedetomidine administration by continuous intravenous infusion, ascertained from anesthesia records. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol. The primary outcome was POD occurring within 7 days after surgery. Documented POD diagnoses were accepted as confirmed events; when no explicit diagnosis was documented, postoperative medical and nursing records were retrospectively reviewed by trained anesthesiologists and intensivists blinded to intraoperative dexmedetomidine exposure. Secondary outcomes included in-hospital mortality and hospital length of stay. Multivariable regression, propensity score matching, subgroup and interaction analyses, and E-value analysis were used to evaluate the robustness of the dexmedetomidine-POD association.
The second component used archived plasma samples and linked clinical data from a previously established prospective observational cohort of adults undergoing cardiac surgery with CPB who were enrolled between April 2023 and September 2024. In the original cohort, intraoperative dexmedetomidine use was determined by the treating anesthesiologist and was not influenced by the study investigators. POD within 7 days after surgery was prospectively assessed, and participants were followed until hospital discharge. Plasma samples had been collected preoperatively, at the end of surgery, and 24 h postoperatively and stored for subsequent analyses. The original prospective cohort enrollment and perioperative biospecimen collection were approved by the Medical Ethics Committee of Tongji Hospital under Approval No. TJ-IRB20231224. The current study, including secondary analyses of archived clinical data and plasma samples, was subsequently approved under Approval No. TJ-IRB202603077. Archived plasma samples were analyzed for MMP-8, and perioperative MMP-8 levels and changes were evaluated in relation to dexmedetomidine exposure and POD. Additional analyses assessed the discriminatory value of perioperative MMP-8 measures for POD and their potential statistical mediating role in the association between intraoperative dexmedetomidine use and POD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort - Dexmedetomidine Exposed | – | Drug: DexmedetomidinePatients in the retrospective multicampus cohort who underwent cardiac surgery with cardiopulmonary bypass between January 2015 and December 2022 and received intraoperative dexmedetomidine by continuous intravenous infusion as part of routine anesthetic care. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and was not assigned by the study protocol. |
| Retrospective Cohort - No Dexmedetomidine Exposure | – | –Patients in the retrospective multicampus cohort who underwent cardiac surgery with cardiopulmonary bypass between January 2015 and December 2022 and did not receive intraoperative dexmedetomidine. |
| Prospective Cohort - Dexmedetomidine Exposed | – | Drug: DexmedetomidineParticipants in the previously established prospective observational cohort who underwent cardiac surgery with cardiopulmonary bypass between April 2023 and September 2024 and received intraoperative dexmedetomidine as part of routine anesthetic care. Dexmedetomidine use was determined by the treating anesthesiologist and was not influenced by the study investigators. Archived perioperative plasma samples from these participants were used for the present MMP-8 analyses. |
| Prospective Cohort - No Dexmedetomidine Exposure | – | –Participants in the previously established prospective observational cohort who underwent cardiac surgery with cardiopulmonary bypass between April 2023 and September 2024 and did not receive intraoperative dexmedetomidine. Archived perioperative plasma samples from these participants were used for the present MMP-8 analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18 years or older who underwent cardiac surgery with cardiopulmonary bypass. The retrospective cohort included eligible patients treated at three campuses of Tongji Hospital between January 2015 and December 2022. The prospective biomarker cohort consisted of participants enrolled between April 2023 and September 2024 for whom archived perioperative plasma samples and linked clinical data were available.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
- For the retrospective cohort, eligible patients undergoing cardiac surgery with CPB at the three participating campuses of Tongji Hospital between January 2015 and December 2022.
- For the prospective biomarker cohort, eligible participants enrolled between April 2023 and September 2024 with archived plasma samples collected preoperatively, at the end of surgery, and 24 h postoperatively, together with linked clinical data.
Key exclusion criteria (5 listed)
- Conditions precluding dexmedetomidine use, including second- or third-degree atrioventricular block without a pacemaker, uncontrolled hypotension, acute cerebrovascular disease, or known hypersensitivity to dexmedetomidine.
- Severe neurological or psychiatric disorders, including a history of treatment for severe mental illness.
- Inability to communicate effectively because of severe hearing, visual, or speech impairments.
- Pregnancy or breastfeeding.
- Emergency 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 |
|---|---|---|
| DexmedetomidineIntraoperative dexmedetomidine administration during cardiac surgery with cardiopulmonary bypass was an observed clinical exposure. The decision to administer dexmedetomidine, including its dose, timing, and duration, was made by the treating anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned or standardized by the study protocol. | Drug | Prospective Cohort - Dexmedetomidine Exposed, Retrospective Cohort - Dexmedetomidine Exposed |
Primary outcome
Incidence of Postoperative Delirium
Time frame: From the end of surgery through postoperative day 7
The number and proportion of participants who experienced at least one episode of postoperative delirium within 7 days after surgery. In the retrospective cohort, POD was ascertained from postoperative medical and nursing records using adapted DSM-5 criteria, with blinded review when no explicit diagnosis was documented. In the prospective cohort, POD was assessed prospectively by trained anesthesiologists and intensivists using the CAM-ICU.
2 secondary outcomes
Hospital Length of Stay
Time frame: From hospital admission through hospital discharge during the index hospitalization, an average of approximately 3 weeks.
In-Hospital All-Cause Mortality
Time frame: From the end of surgery until death or hospital discharge, whichever occurred first, an average of approximately 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication, together with relevant analytic code, may be made available upon reasonable request to the corresponding author, subject to review by the study team and compliance with institutional ethics, data governance, and participant privacy requirements.
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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.
Qin Zhang principal investigator
Tongj Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Shusheng Li 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 4 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: finished, as of the sponsor's last update on 9 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Postoperative Delirium (time frame: From the end of surgery through postoperative day 7). 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 9 Sep 2026.