Artificial Intelligence and Postoperative Acute Kidney Injury

Non-cardiac Surgery Clinical Trial

Official title:

Development and Prospective Validation of an Artificial Intelligence Model to Predict Postoperative Acute Kidney Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04705064
• Other study ID #: 2012-069-1180
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2021
• Source: Seoul National University Hospital
• Contact: Hyung-Chul Lee, MD.PhD
• Phone: +821024566336
• Email: vital[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to develop and validate an artificial intelligence model that predicts postoperative acute kidney injury.

Description:

Postoperative acute kidney injury is known to increase the length of hospital stay and healthcare cost. A lot of risk prediction models have been developed for identifying patients at increased risk of postoperative acute kidney injury. Recent advances in artificial intelligence make it possible to manage and analyze big data. Prediction model using an artificial intelligence and large-scale data can improve the accuracy of prediction performance. Furthermore, the use of an artificial intelligence may be a useful adjuvant tool in making clinical decisions or real-time prediction if it is integrated into the electrical medical record systems. However, before implementing an artificial intelligence model into the clinical setting, prospective evaluation of an artificial intelligence model's real performance is essential. However, to our knowledge, there was no artificial intelligence model for prediction of postoperative acute kidney injury, which was prospectively evaluated. Therefore, we aimed to develop an artificial intelligence model which predicts postoperative acute kidney injury and evaluate the model's performance prospectively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: February 1, 2022
• Est. primary completion date: May 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients undergoing non-cardiac surgery

Exclusion Criteria:

• Age under 18 years

• Surgery duration < 1 hour

• Transplantation surgery

• Nephrectomy

• Cardiac surgery

• Patients who had severe kidney dysfunction preoperatively as follows:

• Serum creatinine = 4 mg/dl

• Estimated glomerular filtration rate <15 ml/min/1.73m2

• History of renal replacement therapy

• Patients who had no results of preoperative or postoperative serum creatinine

Related Conditions & MeSH terms

• Acute Kidney Injury
• Non-cardiac Surgery

Intervention

Diagnostic Test:
• Prediction of postoperative acute kidney injury using an artificial intelligence
The performance of an artificial intelligence model to predict postoperative acute kidney injury will be tested prospectively.

Locations

Country	Name	City	State
Korea, Republic of	Hyung-Chul Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of postoperative acute kidney injury	postoperative acute kidney injury (diagnosed by KDIGO criteria using peak serum creatinine level) included all acute kidney injury events regardless of acute kidney injury severity	during the postoperative seven days