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
-
-
-
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.
|
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.
|
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.
|
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
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.