Acute Kidney InjuryNCT05986474
Development of Synthetic Medical Data Generation Technology to Predict Postoperative Complications
An observational study of Acute Kidney Injury and Surgery-Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
<Development of synthetic medical data generation technology to predict postoperative complications> In order to develop a model for predicting the occurrence of complications after surgery, it is necessary to establish a cohort along with statistical indicators related to the occurrence of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Surgery-Complications, Nephropathy
- How many people
- 410,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Mar 2021to 25 Mar 2023
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years who underwent non-cardiothoracic and non-vascular surgery
Who may be able to join
- Patients over 18 years.
- Non-cardiothoracic and non-vascular surgery from five departments (general surgery, obstetrics and gynecology (OBGY), urologic surgery, neurosurgery, and orthopedic surgery)
Who cannot join
- 1) no information of baseline (≤90 days before surgery) or follow-up (≤7 days after surgery) renal function
- 2) exclusive surgery, including surgeries of deceased patients or surgery that directly affect renal function (partial or total nephrectomy, kidney transplantation)
- 3) preoperative advanced kidney dysfunction, including preoperative serum creatinine (SCr) ≥4.0 mg/dL, baseline eGFR (estimated glomerular filtration rate) <15 mL/min/1.73 m2, preoperative kidney replacement therapy history, or AKI history within 2 weeks of surgery
- 4) surgery other than general or spinal anesthesia (local anesthesia or monitored anesthesia care)
- 5) missing covariates.
Trial locations and contacts
1 site in 1 country.
About this study
<Development of synthetic medical data generation technology to predict postoperative complications>
In order to develop a model for predicting the occurrence of complications after surgery, it is necessary to establish a cohort along with statistical indicators related to the occurrence of complications. This study aims to combine synthetic medical data based on actual clinical data and develop a predictive model based on synthetic medical data.
Read more
This will allow researchers to conduct research only with synthetic data without dealing with actual medical data, allowing them to use and process data without legal constraints, and to create as much data as they want based on various preprocessed, standardized, and labeled raw data.
Patients from three hospitals in Korea (Seoul National University Hospital, Seoul National University Bundang Hospital, Seoul Metropolitan City-Boramae Medical Center) were enrolled for the study.
Medical data (both clinical and laboratory) from 410,000 patients who were conducted surgery between 2005 and 2020 were collected to evaluate the performance of the prediction model using AKI-based prediction model development and external verification.
Based on the collected patient data, synthetic medical data were combined using the machine learning algorithm, and the anonymity and re-identification of the synthesized medical data were evaluated.
Also, the development of AI-based prediction model using synthetic medical data and the actual medical data model were compared.
- Conditions
- Acute Kidney Injury, Surgery-Complications, Nephropathy
- Medical subject headings
- Acute Kidney Injury, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Surgical complication 1
Measured: After surgery, within 7 days
Acute kidney disease
Surgical complication 2
Measured: After surgery, within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start26 Mar 2021
- Primary completion27 Sep 2022
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cross-sectional
- Enrolment
- 410,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajeong Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986474
- Sponsor's protocol ID
- H-2102-192-1203
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho JM, Kwon S, Yang S, Park J, Jeong S, Park S, Ryu J, Kim S, Lee J, Lee JP, Yoon HJ, Kim DK, Joo KW, Kim YS, Kim K, Park M, Lee H. Acute kidney injury after non-cardiac major surgery: has it reduced? Clin Kidney J. 2024 Jun 19;17(7):sfae183. doi: 10.1093/ckj/sfae183. eCollection 2024 Jul.
PubMed 39831175
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Synthetic Medical Data Generation Technology to Predict Postoperative Complications
- ClinicalTrials.gov ID
- NCT05986474
- Acronym / sponsor ID
- H-2102-192-1203
- Conditions
- Acute Kidney Injury, Surgery-Complications, Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410,000 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 14 Aug 2023 (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.
<Development of synthetic medical data generation technology to predict postoperative complications>
In order to develop a model for predicting the occurrence of complications after surgery, it is necessary to establish a cohort along with statistical indicators related to the occurrence of complications. This study aims to combine synthetic medical data based on actual clinical data and develop a predictive model based on synthetic medical data.
This will allow researchers to conduct research only with synthetic data without dealing with actual medical data, allowing them to use and process data without legal constraints, and to create as much data as they want based on various preprocessed, standardized, and labeled raw data.
Patients from three hospitals in Korea (Seoul National University Hospital, Seoul National University Bundang Hospital, Seoul Metropolitan City-Boramae Medical Center) were enrolled for the study.
Medical data (both clinical and laboratory) from 410,000 patients who were conducted surgery between 2005 and 2020 were collected to evaluate the performance of the prediction model using AKI-based prediction model development and external verification.
Based on the collected patient data, synthetic medical data were combined using the machine learning algorithm, and the anonymity and re-identification of the synthesized medical data were evaluated.
Also, the development of AI-based prediction model using synthetic medical data and the actual medical data model were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years who underwent non-cardiothoracic and non-vascular surgery
Key inclusion criteria (2 listed)
- Patients over 18 years.
- Non-cardiothoracic and non-vascular surgery from five departments (general surgery, obstetrics and gynecology (OBGY), urologic surgery, neurosurgery, and orthopedic surgery)
Key exclusion criteria (5 listed)
- 1) no information of baseline (≤90 days before surgery) or follow-up (≤7 days after surgery) renal function
- 2) exclusive surgery, including surgeries of deceased patients or surgery that directly affect renal function (partial or total nephrectomy, kidney transplantation)
- 3) preoperative advanced kidney dysfunction, including preoperative serum creatinine (SCr) ≥4.0 mg/dL, baseline eGFR (estimated glomerular filtration rate) <15 mL/min/1.73 m2, preoperative kidney replacement therapy history, or AKI history within 2 weeks of surgery
- 4) surgery other than general or spinal anesthesia (local anesthesia or monitored anesthesia care)
- 5) missing covariates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute kidney injury
Time frame: After surgery, within 7 days
Surgical complication 1
Acute kidney disease
Time frame: After surgery, within 3 months
Surgical complication 2
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 14 Aug 2023.
- Derived from this study: PubMed 39831175Cho JM, Kwon S, Yang S, Park J, Jeong S, Park S, Ryu J, Kim S, Lee J, Lee JP, Yoon HJ, Kim DK, Joo KW, Kim YS, Kim K, Park M, Lee H. Acute kidney injury after non-cardiac major surgery: has it reduced? Clin Kidney J. 2024 Jun 19;17(7):sfae183. doi: 10.1093/ckj/sfae183. eCollection 2024 Jul.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Kidney Injury and Surgery-Complications, run by Seoul National University Hospital 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 2 inclusion and 5 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 14 Aug 2023. 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?
Acute kidney injury (time frame: After surgery, within 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05986474, which also lists 1 linked publication.
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 14 Aug 2023.