Back to resultsPrediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence (PRIME)
Primary Purpose
Acute Kidney Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PRIME solution
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring Acute kidney injury, Artificial intelligence, Explainable AI, Prediction
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
Sites / Locations
- Bundang Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Usual care group
Arm Description
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. The user-care group continues the existing treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
incidence of AKI
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)
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
Patients who underwent renal replacement therapy
death
patient who died during hospitalization
Full Information
NCT ID
NCT05937451
First Posted
May 22, 2023
Last Updated
July 27, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05937451
Brief Title
Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence
Acronym
PRIME
Official Title
Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence: The PRIME Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute kidney injury, Artificial intelligence, Explainable AI, Prediction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1438 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The usual-care group does not receive analysis results. The user-care group continues the existing treatment.
Intervention Type
Other
Intervention Name(s)
PRIME solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
physician's behavior change
Description
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.
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
Secondary Outcome Measure Information:
Title
incidence of AKI
Description
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.
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
Title
severe AKI (stage 2 or 3)
Description
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
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
Title
renal replacement therapy
Description
Patients who underwent 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
Title
death
Description
patient who died during hospitalization
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sejoong Kim, MD, PhD
Phone
+821094964899
Email
sejoong2@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Giae Yun, MD
Phone
+821063268313
Email
giaeyun0106@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sejoong Kim, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bundang Seoul National University Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence
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