Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence

NCT05937451 | Unknown

• 1 other identifier: PRIME
• Study Type: interventional
• Target: 1,438
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Artificial intelligence; Explainable AI; Prediction

Outcome Measures

Primary Outcomes (1)

• physician's behavior change

  Physician's pattern of care changed after receiving AI prediction information The primary category of outcomes was the change in clinicians' behavior, including clinicians' medical treatment patterns, instances of overlooked AKI, and clinicians' consultation patterns. Medical treatment patterns of clinicians were classified into the following 5 categories: Patient assessment, Review of medication, Imaging workup, Monitoring hemodynamic stability, Evaluate furthermore. Overlooked AKI was defined as the absence of a follow-up Scr measurement within 2 weeks after AKI. Consultation to the nephrology division was classified into the following 3 outcomes: no consultation, early consultation, and late consultation. Early consultation was defined as consultation within 3 days from the AKI prediction. Consults issued more than 3 days after the AKI prediction were considered late consultations.

  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 (4)

• incidence of AKI

  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

• severe AKI (stage 2 or 3)

  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

• renal replacement therapy

  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

• death

  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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Other: PRIME solution

Usual care group

NO INTERVENTION

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

Interventions

PRIME solution 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.

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sejoong Kim, MD, PhD

  Seoul National University Bundang Hospital

  STUDY CHAIR

Central Study Contacts

Sejoong Kim, MD, PhD

CONTACT

+821094964899; sejoong2@snu.ac.kr

Giae Yun, MD

CONTACT

+821063268313; giaeyun0106@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 10, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)