Acute Kidney InjuryPRIMENCT05937451
Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence
A study testing PRIME solution in people with Acute Kidney Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- PRIME solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,438 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients aged > 18 years
- Admitted to the Department of Nephrology, Geriatrics, Urology, Surgery, and Orthopedics
- written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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.
Read the 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
- Being tested
- PRIME solution
- Keywords
- Acute kidney injury, Artificial intelligence, Explainable AI, Prediction
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
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
Measured: 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
Patients who underwent renal replacement therapy
Measured: 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
patient who died during hospitalization
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sejoong Kim, Seoul National University Hospital
- Investigators
- Sejoong Kim, MD, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937451
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Jul 2023
- First submitted
- 22 May 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence: The PRIME Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05937451
- Acronym / sponsor ID
- PRIME / PRIME
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Artificial intelligence, Explainable AI, Prediction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,438 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: PRIME solutionThe intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission. |
| Usual care group | No intervention | –The usual-care group does not receive analysis results. The user-care group continues the existing treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients aged > 18 years
- Admitted to the Department of Nephrology, Geriatrics, Urology, Surgery, and Orthopedics
- written consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIME solutionThe 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. | Other | Intervention group |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sejoong Kim, MD, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME solution in people with Acute Kidney Injury, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sejoong Kim, MD, PhD (+821094964899, sejoong2@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.