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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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