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

September 19, 2025 updated by: Ji-Hoon Sim, Asan Medical Center

Development and Validation of the Surgical Mortality Model for Predicting Postoperative Mortality in Non-cardiac Surgery: A Retrospective Multi-center Cohort Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

642377

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

  • South Korea
      • Seoul, South Korea, 05505
        • Asan Medical Center, University of Ulsan College of Medicine

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing non-cardiac surgery at three tertiary hospitals in South Korea (Asan Medical Center, Seoul National University Hospital, and Samsung Medical Center). Patients with preoperative severe renal dysfunction, kidney transplantation, or missing key variables were excluded. A total of 642,377 patients were included for model development and validation.

Description

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 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
Development Cohort
Patients undergoing non-cardiac surgery at Asan Medical Center. This cohort was used to develop the model.
Other: No Intervention: Observational Cohort
Participants underwent non-cardiac surgery and were followed retrospectively without any experimental intervention. Data were collected from electronic medical records and national death registry to assess postoperative mortality outcomes.
Validation Cohort 1
Patients undergoing non-cardiac surgery at Seoul National University Hospital. This cohort was used for external validation.
Other: No Intervention: Observational Cohort
Participants underwent non-cardiac surgery and were followed retrospectively without any experimental intervention. Data were collected from electronic medical records and national death registry to assess postoperative mortality outcomes.
Validation Cohort 2
Patients undergoing non-cardiac surgery at Samsung Medical Center. This cohort was also used for external validation.
Other: No Intervention: Observational Cohort
Participants underwent non-cardiac surgery and were followed retrospectively without any experimental intervention. Data were collected from electronic medical records and national death registry to assess postoperative mortality outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day postoperative mortality
Time Frame: 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.
Up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
180-day postoperative mortality
Time Frame: Up to 180 days after surgery
Death from any cause within 180 days after non-cardiac surgery.
Up to 180 days after surgery
1-year postoperative mortality
Time Frame: Up to 1 year after surgery
Death from any cause within 365 days after non-cardiac surgery.
Up to 1 year after surgery
Overall postoperative mortality
Time Frame: 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.
Through study completion (median follow-up: approximately 5 years, maximum: 13 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Ji-Hoon Sim, MD, PhD, Asan Medical Center

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)

July 30, 2024

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

September 13, 2025

First Submitted That Met QC Criteria

September 19, 2025

First Posted (Estimated)

September 23, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMC [2022-0755]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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