Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

408153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Delirium - Postoperative Cardiac Surgical Procedures Coronary Artery Bypass Graft (CABG) Valve Surgery Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Dexmedetomidine

Intervention Type 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.

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.

Usual care without perioperative dexmedetomidine

Intervention Type 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.

Interventions

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Dexmedetomidine

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.

Intervention Type DRUG

Usual care without perioperative dexmedetomidine

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.

Intervention Type OTHER

Other Intervention Names

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Precedex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No