Mortality PredictionNCT07188636
Prediction of Postoperative Mortality in Patients Undergoing Non-cardiac Surgery: Development and Validation of the Surgical Mortality Model
An observational study of Mortality Prediction, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study aims to develop and validate a simple, accurate model to predict mortality after non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality Prediction
- How many people
- 642,377 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2024to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18 years or older who underwent non-cardiac surgery
Who cannot join
- Patients who underwent obstetric surgeries
- Transplant donors and recipients
- Patients with incomplete data or missing laboratory values
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 05505
About this study
Official title: 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.
Read the 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.
- Conditions
- Mortality Prediction
- Being tested
- No Intervention: Observational Cohort
- Keywords
- surgery, mortality, prediction, model, non cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Development Cohort | Patients undergoing non-cardiac surgery at Asan Medical Center. This cohort was used to develop the model. Receives: 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. Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after surgery
Secondary outcomes (3)
180-day postoperative mortality
Death from any cause within 180 days after non-cardiac surgery.
Measured: Up to 180 days after surgery
1-year postoperative mortality
Death from any cause within 365 days after non-cardiac surgery.
Measured: Up to 1 year after surgery
Overall postoperative mortality
Death from any cause during the entire follow-up period after non-cardiac surgery.
Measured: Through study completion (median follow-up: approximately 5 years, maximum: 13 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start30 Jul 2024
- Primary completion20 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mortality PredictionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 642,377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hoon Sim, Asan Medical Center
- Investigators
- Ji-Hoon Sim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188636
- Sponsor's protocol ID
- AMC [2022-0755]
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Surgical Mortality Model for Predicting Postoperative Mortality in Non-cardiac Surgery: A Retrospective Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT07188636
- Acronym / sponsor ID
- AMC [2022-0755]
- Conditions
- Mortality Prediction
- Keywords
- surgery, mortality, prediction, model, non cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642,377 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Development Cohort | – | Other: No Intervention: Observational CohortPatients undergoing non-cardiac surgery at Asan Medical Center. This cohort was used to develop the model. |
| Validation Cohort 1 | – | Other: No Intervention: Observational CohortPatients undergoing non-cardiac surgery at Seoul National University Hospital. This cohort was used for external validation. |
| Validation Cohort 2 | – | Other: No Intervention: Observational CohortPatients undergoing non-cardiac surgery at Samsung Medical Center. This cohort was also used for external validation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older who underwent non-cardiac surgery
Key exclusion criteria (3 listed)
- Patients who underwent obstetric surgeries
- Transplant donors and recipients
- Patients with incomplete data or missing laboratory values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortParticipants 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. | Other | Development Cohort, Validation Cohort 1, Validation Cohort 2 |
Primary outcome
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.
3 secondary outcomes
180-day postoperative mortality
Time frame: Up to 180 days after surgery
1-year postoperative mortality
Time frame: Up to 1 year after surgery
Overall postoperative mortality
Time frame: Through study completion (median follow-up: approximately 5 years, maximum: 13 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji-Hoon Sim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality Prediction, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative mortality (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.