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

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
      • Taichung, Taichung City, Taiwan, 40447
        • China Medical University Hospital

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:
  • Precedex
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.
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.
Day 0 through Day 30 after index surgery
Myocardial infarction within 30 days
Time Frame: Day 0 through Day 30 after index surgery
Myocardial infarction by ICD-10-CM/SNOMED CT; exclude-prior-to-window; cumulative incidence and Cox HR.
Day 0 through Day 30 after index surgery
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
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
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
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.

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

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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