Clinical trial NCT05937451: Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence
Official title: Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence: The PRIME Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Artificial intelligence
Explainable AI
Prediction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 1438
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the occurrence of acute kidney injury (AKI) in inpatients when information from the 'PRIME solution' (AKI prediction program utilizing artificial intelligence) is provided. The main questions it aims to answer are: •\[When Artificial intelligence (AI) provides information regarding AKI occurrence prediction within 48 hours, what would change in the physician's behavior?\] •\[If provided with AI information, what would be the incidence of AKI, severe AKI (stage 2 or 3), kidney replacement therapy, and changes in mortality during hospitalization?\] In the case of the intervention group that receives AI information, autonomous treatment is conducted by referring to AI prediction information. Researchers will compare it with a usual-care group that does not receive AI prediction results.

Detailed description: The investigators designed a prospective, investigator-initiated, single-center, single-blinded, randomized controlled study with two experimental groups. A total of 1438 participants with hospitalized patients will be enrolled and randomized into two groups; intervention or usual-care groups. The investigators will apply an AKI prediction model based on the patient's demographic. The investigators will collect data on vital signs, laboratory test results, medication history, and surgical records. The investigators provide information on whether AKI develops within 48 hours and the top 10 explanatory factors for predicting AKI to the physician. The intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission. The usual-care group does not receive analysis results.

Eligibility criteria: Inclusion Criteria:

* Inpatients aged \> 18 years
* Admitted to the Department of Nephrology, Geriatrics, Urology, Surgery, and Orthopedics
* written consent

Exclusion Criteria:

* Patients with a scheduled hospital stay of 2 days or less
* Patients who have been hospitalized for more than 8 days since the date of hospitalization
* Patients scheduled to be discharged the next day
* Patients with last measured serum creatinine greater than 4.0 mg/dL or less than Estimated Glomerular Filtration Fate Chronic Kidney Disease Epidemiology Collaboration (eGFR-CKD-EPI) 15 ml/min/1.73 m2
* Patients undergoing dialysis (Hemodialysis, peritoneal dialysis) due to end-stage renal disease
* Declined to participate

Primary outcomes:
measure: physician's behavior change
timeFrame: From the date of radomization until the patient is discharged or date of death from any cause, whichever came first, assessed up to 8 days after admission
Secondary outcomes:
measure: incidence of AKI
timeFrame: From the date of randomization until the patient is discharged or date of death from any cause, whichever came first, assessed up to 8 days after admission
measure: severe AKI (stage 2 or 3)
timeFrame: From the date of randomization until the patient is discharged or date of death from any cause, whichever came first, assessed up to 8 days after admission
measure: renal replacement therapy
timeFrame: From the date of randomization until the patient is discharged or date of death from any cause, whichever came first, assessed up to 8 days after admission
measure: death
timeFrame: From the date of randomization until the patient is discharged or date of death from any cause, whichever came first, assessed up to 8 days after admission
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sejoong Kim, MD, PhD
role: STUDY_CHAIR
References: