Prediction and Management of Acute Kidney Injury With Explainable Artificial Intelligence: The PRIME Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,438
- 试验地点
- 2
- 主要终点
- physician's behavior change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients aged > 18 years
- •Admitted to the Department of Nephrology, Geriatrics, Urology, Surgery, and Orthopedics
- •written consent
排除标准
- •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
结局指标
主要结局
physician's behavior change
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Sejoong Kim
Associated professor
Seoul National University Hospital