Prediction of Postoperative Mortality in Patients Undergoing Non-cardiac Surgery: Development and Validation of the Surgical Mortality Model

Completed

• Conditions: Mortality Prediction

• Registration Number: NCT07188636
• Lead Sponsor: Asan Medical Center

Brief Summary

This study aims to develop and validate a simple, accurate model to predict mortality after non-cardiac surgery.

Detailed Description

This retrospective multi-center cohort study aimed to develop and externally validate a predictive model for postoperative mortality in adult patients undergoing non-cardiac surgery. The development cohort included patients from Asan Medical Center, and validation was performed using data from Seoul National University Hospital and Samsung Medical Center. Mortality was assessed at 30 days, 180 days, 1 year, and overall follow-up. The model was developed using LASSO logistic regression and evaluated for discrimination and calibration across cohorts.

Study Timeline

• Study Start: 2024-07-30
• Primary Completion: 2024-12-20
• Study Completion: 2025-01-20
• Status Verified: 2025-09
• Study First Submitted: 2025-09-13
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642377

Inclusion Criteria

• Patients aged 18 years or older who underwent non-cardiac surgery

Exclusion Criteria

• Patients who underwent obstetric surgeries
• Transplant donors and recipients
• Patients with incomplete data or missing laboratory values

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day postoperative mortality	Up to 30 days after surgery	Death from any cause occurring within 30 days after non-cardiac surgery, ascertained from hospital records and national death registry data.

Secondary Outcome Measures

Name	Time	Method
180-day postoperative mortality	Up to 180 days after surgery	Death from any cause within 180 days after non-cardiac surgery.
1-year postoperative mortality	Up to 1 year after surgery	Death from any cause within 365 days after non-cardiac surgery.
Overall postoperative mortality	Through study completion (median follow-up: approximately 5 years, maximum: 13 years)	Death from any cause during the entire follow-up period after non-cardiac surgery.

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, South Korea