- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07249164
Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery
November 24, 2025 updated by: China Medical University Hospital
Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery: A Real-World Retrospective Cohort Study Using the TriNetX Network
This observational study uses de-identified electronic health record data from the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01) to examine whether perioperative dexmedetomidine (DEX) is associated with 30-day outcomes after adult cardiac surgery.
Adults aged 18-100 years undergoing first-time coronary artery bypass grafting or heart valve surgery are included.
Exposure is any DEX administration from 24 hours before to 48 hours after the index operation; comparators receive no DEX in this window.
The primary outcome is delirium within 30 days.
Secondary outcomes are 30-day all-cause mortality, acute kidney injury, pneumonia, sepsis, red blood cell transfusion/major bleeding, myocardial infarction, ischemic stroke/transient ischemic attack, atrial fibrillation, mechanical ventilation >96 hours (days 4-30), and 30-day readmission (days 1-30).
No treatments are assigned by investigators and no identifiable information is used.
Findings aim to inform perioperative sedation strategies in routine cardiac surgery care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a retrospective cohort study using de-identified data from the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01).
Adults aged 18-100 years undergoing first-time coronary artery bypass grafting or heart valve surgery will be identified.
Perioperative exposure is defined as any dexmedetomidine administration from 24 hours before to 48 hours after the index surgery; the comparison cohort consists of patients without dexmedetomidine in this window.
Clinical outcomes within 30 days after surgery include delirium as the primary outcome and a range of major postoperative complications and mortality.
Propensity scores based on demographics, comorbidities, baseline medications and laboratory tests will be used to match or adjust between exposure groups, with balance assessed using standardized mean differences.
Time-to-event analyses will use Cox proportional hazards models and Kaplan-Meier curves, with multiplicity controlled using the Benjamini-Hochberg false discovery rate.
All analyses use only de-identified data within the TriNetX platform, with no direct contact with patients or access to identifiers.
Study Type
Observational
Enrollment (Actual)
408153
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taichung City
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Taichung, Taichung City, Taiwan, 40447
- China Medical University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults aged 18-100 years undergoing first-time CABG or valve surgery in the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01); de-identified EHR data; exposure defined as perioperative dexmedetomidine -24 to +48 h; comparator without dexmedetomidine in that window.
Description
Inclusion Criteria:
- Age 18-100 years.
- First-time CABG or heart valve surgery within TriNetX during 2010-01-01 to 2025-07-01.
- ≥90 days pre-operative observable data and a 30-day post-operative window (death ≤30 days counts as complete).
- Index surgery, exposure window (-24 to +48 h), and outcomes identifiable from standardized platform codes/fields.
Exclusion Criteria:
- End-stage renal disease or dialysis within 90 days before index surgery (ICD-10-CM N18.6, Z49, Z99.2).
- Not first-time CABG/valve in the same admission.
- Missing required fields or conflicting records preventing unique case definition.
- Unable to confirm exposure window or outcomes within the platform.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Perioperative Dexmedetomidine
Adults undergoing first-time CABG or valve surgery with any dexmedetomidine recorded from 24 h before to 48 h after the index surgery on TriNetX; exposure observed in routine care, not assigned by investigators.
|
Exposure in routine care within -24 to +48 hours of the index cardiac surgery; dose and regimen not protocol-assigned; observational only; exposure captured from medication records and used to define the dexmedetomidine cohort.
Other Names:
|
|
No Perioperative Dexmedetomidine
Same surgical cohort with no dexmedetomidine recorded within the -24 to +48 h window; use of dexmedetomidine outside this window allowed; comparison reflects perioperative sedation strategy.
|
No dexmedetomidine administered within -24 to +48 hours of the index surgery; all other management per routine care; observational comparator; dexmedetomidine use outside this window permitted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delirium within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Delirium identified from EHR codes (ICD-10-CM/SNOMED CT).
TriNetX "exclude prior to window" enabled; patients with delirium before Day 0 excluded from the risk set.
Estimates reported as cumulative incidence and Cox HR with 95% CI.
|
Day 0 through Day 30 after index surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Death status from death registry/EHR status flags; exclude-prior-to-window enabled; cumulative incidence and Cox HR.
|
Day 0 through Day 30 after index surgery
|
|
Acute kidney injury within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Acute kidney injury by ICD-10-CM/SNOMED CT codes; exclude-prior-to-window; cumulative incidence and Cox HR.
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Day 0 through Day 30 after index surgery
|
|
Pneumonia within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Pneumonia by ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
|
Day 0 through Day 30 after index surgery
|
|
Sepsis within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Sepsis by ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
|
Day 0 through Day 30 after index surgery
|
|
Red blood cell transfusion or major haemorrhage within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Any red blood cell transfusion or major bleeding by CPT/HCPCS and ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
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Day 0 through Day 30 after index surgery
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Myocardial infarction within 30 days
Time Frame: Day 0 through Day 30 after index surgery
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Myocardial infarction by ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
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Day 0 through Day 30 after index surgery
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Ischemic stroke or transient ischemic attack within 30 days
Time Frame: Day 0 through Day 30 after index surgery
|
Ischemic stroke/transient ischemic attack by ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
|
Day 0 through Day 30 after index surgery
|
|
Atrial fibrillation within 30 days
Time Frame: Day 0 through Day 30 after index surgery
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Atrial fibrillation by ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
|
Day 0 through Day 30 after index surgery
|
|
Mechanical ventilation >96 hours
Time Frame: Day 4 through Day 30 after index surgery
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Duration of invasive mechanical ventilation >96 h using ICD-10-PCS/CPT/HCPCS/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
|
Day 4 through Day 30 after index surgery
|
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30-day readmission
Time Frame: Day 1 through Day 30 after index surgery
|
Any all-cause hospital readmission from encounter/admission flags (diagnoses on readmission as coded); exclude-prior-to-window; cumulative incidence and Cox HR.
|
Day 1 through Day 30 after index surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: En-Bo Wu, MD, Department of Anesthesiology, China Medical University Hospital, Taichung City, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Poon WH, Ling RR, Yang IX, Luo H, Kofidis T, MacLaren G, Tham C, Teoh KLK, Ramanathan K. Dexmedetomidine for adult cardiac surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2023 Mar;78(3):371-380. doi: 10.1111/anae.15947. Epub 2022 Dec 19.
- Caetano da Silva L, Tapioca V, Viana P, Pereira EM, Gibicoski T, Amaral S. Dexmedetomidine for delirium prevention after cardiac surgery: An updated systematic review and meta-analysis with trial sequential analysis. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101578. doi: 10.1016/j.accpm.2025.101578. Epub 2025 Jun 24.
- Wang HB, Jia Y, Zhang CB, Zhang L, Li YN, Ding J, Wu X, Zhang Z, Wang JH, Wang Y, Yan FX, Yuan S, Sessler DI. A randomised controlled trial of dexmedetomidine for delirium in adults undergoing heart valve surgery. Anaesthesia. 2023 May;78(5):571-576. doi: 10.1111/anae.15983. Epub 2023 Feb 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
July 31, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
November 24, 2025
First Posted (Actual)
November 25, 2025
Study Record Updates
Last Update Posted (Actual)
November 25, 2025
Last Update Submitted That Met QC Criteria
November 24, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergence Delirium
- Postoperative Complications
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Imidazoles
- Dexmedetomidine
Other Study ID Numbers
- CMUH114-REC3-181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This retrospective observational study uses de-identified data from the TriNetX Global Collaborative Network.
Investigators do not receive identifiable information or re-identification keys.
The Data Use Agreement with TriNetX and participating health care organizations prohibits sharing or redistributing line-level individual participant data outside the platform.
Only aggregate results and model estimates will be shared (e.g., tables, figures); study documents and analysis code may be provided on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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