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OpenTrials
Completed

NCT Number: NCT05986474

Development of Synthetic Medical Data Generation Technology to Predict Postoperative Complications

<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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Acute kidney injury

    Time frame: After surgery, within 7 days

    Surgical complication 1

  2. Acute kidney disease

    Time frame: After surgery, within 3 months

    Surgical complication 2

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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