PRIME: Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05937451

Collaborator

(none)

1,438

Enrollment

Location

Arms

Anticipated Duration (Months)

47.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Other: PRIME solution	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1438 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence: The PRIME Randomized Controlled Trial

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention group The intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission.	Other: 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.
No Intervention: Usual care group The usual-care group does not receive analysis results. The user-care group continues the existing treatment.

Arm

Intervention/Treatment

Active Comparator: Intervention group

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

Other: 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.

No Intervention: Usual care group

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

Outcome Measures

Primary Outcome Measures

physician's behavior change [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]
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.

Secondary Outcome Measures

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]
AKI is defined as any of the following (NotGraded): Increase in SCr by ≥ 0.3mg/dl (≥26.5umol/l) within 48 hours;or Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7days; or Urine volume < 0.5ml/kg/h for 6hours.
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]
stage 2: Serum creatinine (SCr) 2.0-2.9 times baseline or Urine output < 0.5ml/kg/h for ≥12hours stage 3: Serum creatinine 3.0 times baseline or increase in serum creatinine to ≥ 4.0 mg/dl or initiation of renal replacement therapy or Urine output < 0.3ml/kg/h for ≥24hours or Anuria for ≥ 12 hours
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]
Patients who underwent renal replacement therapy
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]
patient who died during hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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