The Cost-effectiveness of Artificial Intelligence Acute Kidney Injury Prediction Auxiliary Software (Acura AKI)

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury; Intensive Care; Renal Replacement Therapy

• Registration Number: NCT06685367
• Lead Sponsor: Huede Healthtech Co., Ltd.

Brief Summary

"Huede" AI Aided AKI Prediction Software, Acura AKI, uses machine learning algorithms to predict the risk of AKI within the next 24 hours and provide a ranking of feature importance. By using Acura AKI, physicians can assess the risk of AKI, focusing on high-risk patients to provide care decisions. This study will be conducted in a prospective randomized clinical trial in adult ICUs, implementing the Acura AKI system for predicting AKI. The study aims to determine whether early prediction and intervention using the Acura AKI system can improve the outcomes of critically ill patients with adverse kidney conditions. The study endpoint is to evaluate the cost-effectiveness of using Acura AKI, including the incidence of AKI, dialysis rates, mortality rates, length of hospital stay, and treatment costs.

Detailed Description

"Huede" AI Aided AKI Prediction Software, Acura AKI, uses machine learning algorithms to predict the risk of AKI within the next 24 hours. It has undergone cross-hospital validation at four medical centers in Taiwan (Taichung Veterans General Hospital, Mackay Memorial Hospital, National Cheng Kung University Hospital, and Kaohsiung Medical University Hospital), successfully obtaining invention patents in Taiwan and the United States, as well as receiving a software medical device license from the Taiwan Food and Drug Administration. Acura AKI is installed on the hospital's servers, where it processes patient physiological data, laboratory parameters, and medication information to infer the risk of AKI occurring within 24 hours. It also provides a ranking of feature importance. By using Acura AKI, physicians can assess the risk of AKI, focusing on high-risk patients to provide care decisions.

This study will be conducted in a prospective randomized clinical trial in adult ICUs, implementing the Acura AKI system for predicting AKI. In the intervention group with Acura AKI system, physicians will be proactively notified via sending alarm message when Acura AKI identifies a high-risk patient population. After receiving alarm message, physicians and pharmacists will provide feedback and recommendations, including blood pressure, fluid management, infusion options, medication adjustment suggestions, and dialysis recommendations. The study aims to determine whether early prediction and intervention using the Acura AKI system can improve the outcomes of critically ill patients with adverse kidney conditions. Additionally, the researchers will collect 20ml of urine from Acura AKI identified patients to test for urinary biomarkers predictive of AKI then verify the performance of Acura AKI with these urinary biomarkers. The study endpoint is to evaluate the cost-effectiveness of using Acura AKI, including the incidence of AKI, dialysis rates, mortality rates, length of hospital stay, and treatment costs.

Study Timeline

• Study First Submitted: 2024-10-11
• Study Start: 2024-10-17
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-10
• Last Update Submitted: 2024-11-10
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

Inclusion Criteria

• Over 20 years old
• Admitted to adult ICU
• Hospital stay of more than 30 hours

Exclusion Criteria

• Known to have acute kidney injury at enrollment
• Currently undergoing hemodialysis treatment
• No available blood or urine test data
• Pregnant women
• HIV-positive patients
• Those who have not provided informed consent form
• Regarded as unsuitable for inclusion in the trial by the researcher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acute kidney injury (AKI) incidence	Assessed from time of randomization to time of AKI occurrence (within 7 days post randomization)	Acute kidney injury (AKI) incidence in ICU. AKI is defined by an increase in KDIGO creatinine stage.

Secondary Outcome Measures

Name	Time	Method
Percentage of recommendations implemented by the primary care team.	24 hours after Randomization	Upon receiving the alert message from the AI algorithm (Acura AKI), nephrologists and ICU pharmacists will review the patient's electronic health record and make treatment suggestions based on AKI bundle care protocols. They will also coordinate with the patient's primary care team to ensure that the recommendations are implemented
Dialysis rate	Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)	Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.
Mortality rate	Assessed from time of randomization to date of death from any cause, within 14 days of randomization	Mortality will be determined from hospital administrative records
Length of hospital stay	Assessed from time of randomization to date of hospital discharge, assessed up to 30 days	The total days of hospitalization stay
Change in treatment costs	Assessed from time of randomization to 60 days post hospital discharge date, accessed up to 90 days	1. Hospital Services \[Room and board (inpatient stays), Intensive care unit (ICU) fees, Emergency department charges, Operating room fees, and Recovery room fees\]; 2. Professional Fees \[Physician services (e.g., consultations, surgery, anesthesia), Nursing services, and Therapist services (physical, occupational, respiratory)\]; 3. Diagnostic Services \[Laboratory tests (blood tests, urine tests), Imaging studies (X-rays, MRI, CT scans), Biopsies, Electrocardiograms (EKGs), and Other diagnostic procedures\]; 4. Medication and Pharmacy \[Prescription drugs, Intravenous medications, and Anesthesia drugs\]; 5. Medical Supplies and Equipment \[Surgical supplies, Disposable supplies (syringes, bandages), and Prosthetics and orthotics\]; 6. Rehabilitation Services \[Physical therapy, Occupational therapy, Speech therapy, Cardiac rehabilitation\]
Long term dialysis	From hospital discharge date up to 90 days post discharge date	Receive regular dialysis

Trial Locations

Locations (1)

Taichung Veterans General Hospital (TCVGH); 🇨🇳 Taichung, Taiwan