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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorHuede Healthtech Co., Ltd.

About this trial

"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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 20 years old

Admitted to adult ICU

Hospital stay of more than 30 hours

Disqualifiers

Known to have acute kidney injury at enrollment

Currently undergoing hemodialysis treatment

No available blood or urine test data

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acura AKI

    Device

    When the AI algorithm (Acura AKI) identifies a high-risk AKI patient, nephrologists and ICU pharmacists will receive an alert message. Upon receiving the alert, they 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

Treatment groups

3,600 Participants
are divided into 2 treatment groups
Group A: With Acura AKIExperimental treatment 1 intervention
Group B: Without Acura AKINo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Acute kidney injury (AKI) incidence

Acute kidney injury (AKI) incidence in ICU. AKI is defined by an increase in KDIGO creatinine stage.

Time frame
Assessed from time of randomization to time of AKI occurrence (within 7 days post randomization)

Secondary outcomes

1

Percentage of recommendations implemented by the primary care team.

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

Time frame
24 hours after Randomization
2

Dialysis rate

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.

Time frame
Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
3

Mortality rate

Mortality will be determined from hospital administrative records

Time frame
Assessed from time of randomization to date of death from any cause, within 14 days of randomization
4

Length of hospital stay

The total days of hospitalization stay

Time frame
Assessed from time of randomization to date of hospital discharge, assessed up to 30 days

Other outcomes

Sponsors and contacts

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