Development of Synthetic Medical Data Generation Technology to Predict Postoperative Complications

NCT ID: NCT05986474

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

410000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-26

Study Completion Date

2023-03-25

Brief Summary

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\<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.

Detailed Description

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Conditions

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Acute Kidney Injury Surgery-Complications Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hajeong Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 39831175 (View on PubMed)

Other Identifiers

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H-2102-192-1203

Identifier Type: -

Identifier Source: org_study_id

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