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Completed

NCT Number: NCT07249164

Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery

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.

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Key information

Conditions

Delirium - Postoperative Cardiac Surgical Procedures Confusion Coronary Artery Bypass Graft (CABG) Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Valve Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, Taichung City, 40447, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Usual care without perioperative dexmedetomidine

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery: A Real-World Retrospective Cohort Study Using the TriNetX Network

Important dates

Study start
2010
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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