Clinical trial NCT06685367: The Cost-effectiveness of Artificial Intelligence Acute Kidney Injury Prediction Auxiliary Software (Acura AKI)
Official title: The Cost-effectiveness of Artificial Intelligence Acute Kidney Injury Prediction Auxiliary Software (Acura AKI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Intensive Care
Renal Replacement Therapy
Keywords: Acute Kidney Injury
Intensive Care Units
Critical Ill
Prevention
Artificial Intelligence
Machine Learning
Clinical Decision Support System
Dialysis
Renal Replacement Therapy
Cost-effectiveness
Lead sponsor: Huede Healthtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 3600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute kidney injury (AKI) incidence
timeFrame: Assessed from time of randomization to time of AKI occurrence (within 7 days post randomization)
Secondary outcomes:
measure: Percentage of recommendations implemented by the primary care team.
timeFrame: 24 hours after Randomization
measure: Dialysis rate
timeFrame: Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
measure: Mortality rate
timeFrame: Assessed from time of randomization to date of death from any cause, within 14 days of randomization
measure: Length of hospital stay
timeFrame: Assessed from time of randomization to date of hospital discharge, assessed up to 30 days
measure: Change in treatment costs
timeFrame: Assessed from time of randomization to 60 days post hospital discharge date, accessed up to 90 days
measure: Long term dialysis
timeFrame: From hospital discharge date up to 90 days post discharge date
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital (TCVGH)
Study officials:
affiliation: Taichung Veterans General Hospital (TCVGH)
name: Chun-Te Huang
role: PRINCIPAL_INVESTIGATOR
References: