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NCT Number: NCT06685367

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

"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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intensive Care Kidney Diseases Male Urogenital Diseases Renal Insufficiency Renal Replacement Therapy Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital (TCVGH)

Taichung, Taiwan

Location status: Recruiting

Location contact

Chun-Te Huang

CONTACT

[email protected]

+8864-23592525 ext. 3169

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Acute kidney injury (AKI) incidence

    Time frame: 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 outcomes

  1. Percentage of recommendations implemented by the primary care team.

    Time frame: 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

  2. Dialysis rate

    Time frame: 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.

  3. Mortality rate

    Time frame: 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

  4. Length of hospital stay

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

    The total days of hospitalization stay

  5. Change in treatment costs

    Time frame: Assessed from time of randomization to 60 days post hospital discharge date, accessed up to 90 days

    • Hospital Services [Room and board (inpatient stays), Intensive care unit (ICU) fees, Emergency department charges, Operating room fees, and Recovery room fees]
    • Professional Fees [Physician services (e.g., consultations, surgery, anesthesia), Nursing services, and Therapist services (physical, occupational, respiratory)]
    • Diagnostic Services [Laboratory tests (blood tests, urine tests), Imaging studies (X-rays, MRI, CT scans), Biopsies, Electrocardiograms (EKGs), and Other diagnostic procedures]
    • Medication and Pharmacy [Prescription drugs, Intravenous medications, and Anesthesia drugs]
    • Medical Supplies and Equipment [Surgical supplies, Disposable supplies (syringes, bandages), and Prosthetics and orthotics]
    • Rehabilitation Services [Physical therapy, Occupational therapy, Speech therapy, Cardiac rehabilitation]

  6. Long term dialysis

    Time frame: From hospital discharge date up to 90 days post discharge date

    Receive regular dialysis

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Te Huang

CONTACT

[email protected]

+8864-23592525 ext. 3169

Sponsors and collaborators

Lead sponsor

Huede Healthtech Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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