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NOT YET RECRUITING
NCT07900009

Biomarkers of Postoperative Complications After Cardiac Surgery

Sponsor: Rao Sun

View on ClinicalTrials.gov

Summary

Postoperative delirium and other complications are important adverse outcomes following cardiac surgery. This study will integrate perioperative clinical information with molecular measurements to investigate factors associated with these outcomes and improve early risk assessment. Eligible patients undergoing elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures will be prospectively enrolled. Data collection will include demographic characteristics, medical history, preoperative medications, laboratory findings, surgical and anesthetic characteristics, and postoperative clinical outcomes. Blood samples will be collected before surgery and approximately 24 hours after surgery, processed according to standardized procedures, and stored for subsequent analyses. Molecular investigations will include proteomic and metabolomic profiling and targeted measurement of selected biomarkers. POD will be assessed twice daily by trained research personnel during the first 7 postoperative days or until hospital discharge, whichever occurs first. Standardized, validated delirium assessment instruments will be used in the ICU and after transfer to the ward. Other postoperative complications and recovery outcomes will be recorded prospectively. Analyses will examine associations between clinical characteristics, molecular profiles, and postoperative outcomes. Causal inference methods will be used, where appropriate, to explore the potential causal relevance of candidate biomarkers under explicitly stated assumptions. Interpretable prediction models will be developed using clinical variables, molecular features, or their combination. Model performance will be assessed in terms of discrimination, calibration, and potential clinical utility. Internal validation will be performed, and temporal or external validation will be undertaken where suitable independent data are available.

Official title: Biomarkers and Risk Prediction for Postoperative Delirium and Other Complications After Cardiac Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-11-01

Completion Date

2027-07-31

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

OTHER

no intervention

no intervention