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

NCT07188636 | Completed

• 1 other identifier: AMC [2022-0755]
• Study Type: observational
• Target: 642,377
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mortality Prediction

Keywords

surgery; mortality; prediction; model; non cardiac

Outcome Measures

Primary Outcomes (1)

• 30-day postoperative mortality

  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 Outcomes (3)

• 180-day postoperative mortality

  Up to 180 days after surgery

• 1-year postoperative mortality

  Up to 1 year after surgery

• Overall postoperative mortality

  Through study completion (median follow-up: approximately 5 years, maximum: 13 years)

Study Arms (3)

Development Cohort

Patients undergoing non-cardiac surgery at Asan Medical Center. This cohort was used to develop the model.

Other: No Intervention: Observational Cohort

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

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

Interventions

No Intervention: Observational Cohort OTHER

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.

Development Cohort; Validation Cohort 1; Validation Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

Study Officials

• Ji-Hoon Sim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 23, 2025
• Study Start: July 30, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 20, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)