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

July 27, 2023 updated by: Sejoong Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1438

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Bundang Seoul National University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physician's behavior change
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of AKI
Time Frame: 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.
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Sejoong Kim, MD, PhD, Seoul National University Bundang Hospital

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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