- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04705064
Artificial Intelligence and Postoperative Acute Kidney Injury
January 8, 2021 updated by: Hyung-Chul Lee, Seoul National University Hospital
Development and Prospective Validation of an Artificial Intelligence Model to Predict Postoperative Acute Kidney Injury
The main objective of this study is to develop and validate an artificial intelligence model that predicts postoperative acute kidney injury.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Hyung-Chul Lee
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults patients undergoing non-cardiac surgery
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AI_AKI
Adults patients undergoing non-cardiac surgery
|
The performance of an artificial intelligence model to predict postoperative acute kidney injury will be tested prospectively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the incidence of postoperative acute kidney injury
Time Frame: during the postoperative seven days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
May 31, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 12, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 8, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-069-1180
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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