Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence

NCT ID: NCT05937451

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

The intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission.

Group Type: ACTIVE_COMPARATOR

PRIME solution

Intervention Type: OTHER

The investigators will apply an AKI prediction model (PRIME solution) 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.

Usual care group

The usual-care group does not receive analysis results. The user-care group continues the existing treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRIME solution

The investigators will apply an AKI prediction model (PRIME solution) 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sejoong Kim

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sejoong Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Locations

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Central Contacts

Sejoong Kim, MD, PhD

Role: CONTACT

sejoong2@snu.ac.kr

+821094964899

Giae Yun, MD

Role: CONTACT

giaeyun0106@gmail.com

+821063268313

Other Identifiers

PRIME

Identifier Type: -

Identifier Source: org_study_id