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临床试验/NCT05986474
NCT05986474已完成不适用

Development of Synthetic Medical Data Generation Technology to Predict Postoperative Complications

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 410,000 人开始时间: 2021年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
410,000
试验地点
1
主要终点
Acute kidney disease

研究概览

简要总结

<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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • no information of baseline (≤90 days before surgery) or follow-up (≤7 days after surgery) renal function
  • exclusive surgery, including surgeries of deceased patients or surgery that directly affect renal function (partial or total nephrectomy, kidney transplantation)
  • 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
  • surgery other than general or spinal anesthesia (local anesthesia or monitored anesthesia care)
  • missing covariates.

结局指标

主要结局

Acute kidney disease

时间窗: After surgery, within 3 months

Surgical complication 2

Acute kidney injury

时间窗: After surgery, within 7 days

Surgical complication 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hajeong Lee

Associate Professor

Seoul National University Hospital

研究点 (1)

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