Acute Kidney InjuryNCT06685367
The Cost-effectiveness of Artificial Intelligence Acute Kidney Injury Prediction Auxiliary Software (Acura AKI)
A study testing Acura AKI in people with Acute Kidney Injury and Intensive Care, run by Huede Healthtech Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Kidney Injury, Intensive Care, Renal Replacement Therapy
- What is being tested?
- Acura AKI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 20 years old
- Admitted to adult ICU
- Hospital stay of more than 30 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital (TCVGH)
Taichung
Chun-Te Huang, +8864-23592525 ext. 3169, huangchunte@gmail.com
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 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.
Read the 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.
- Being tested
- Acura AKI
- Keywords
- Acute Kidney Injury, Intensive Care Units, Critical Ill, Prevention, Artificial Intelligence, Machine Learning, Clinical Decision Support System, Dialysis, Renal Replacement Therapy, Cost-effectiveness
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acura AKIDevice
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
| Study group | Role | What they receive |
|---|---|---|
| With Acura AKI | Experimental | The group with Acura AKI will receive the Acura AKI software, which identifies high-risk AKI patients and sends alert messages to nephrologists and ICU pharmacists. Upon receiving the alert, they will make treatment suggestions. Receives: Device: Acura AKI |
| Without Acura AKI | No intervention | The group without Acura AKI will be managed based on standard medical procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury (AKI) incidence
Acute kidney injury (AKI) incidence in ICU. AKI is defined by an increase in KDIGO creatinine stage.
Measured: Assessed from time of randomization to time of AKI occurrence (within 7 days post randomization)
Secondary outcomes (6)
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
Measured: 24 hours after Randomization
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.
Measured: Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
Mortality rate
Mortality will be determined from hospital administrative records
Measured: Assessed from time of randomization to date of death from any cause, within 14 days of randomization
Length of hospital stay
The total days of hospitalization stay
Measured: Assessed from time of randomization to date of hospital discharge, assessed up to 30 days
Change in treatment costs
- 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]
Measured: Assessed from time of randomization to 60 days post hospital discharge date, accessed up to 90 days
Long term dialysis
Receive regular dialysis
Measured: From hospital discharge date up to 90 days post discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start17 Oct 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huede Healthtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chun-Te Huang, Principal investigator, Taichung Veterans General Hospital (TCVGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685367
- Sponsor's protocol ID
- Huede-113001
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost-effectiveness of Artificial Intelligence Acute Kidney Injury Prediction Auxiliary Software (Acura AKI)
- ClinicalTrials.gov ID
- NCT06685367
- Acronym / sponsor ID
- Huede-113001
- Keywords
- Acute Kidney Injury, Intensive Care Units, Critical Ill, Prevention, Artificial Intelligence, Machine Learning, Clinical Decision Support System, Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Huede Healthtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Acura AKI | Experimental | Device: Acura AKIThe group with Acura AKI will receive the Acura AKI software, which identifies high-risk AKI patients and sends alert messages to nephrologists and ICU pharmacists. Upon receiving the alert, they will make treatment suggestions. |
| Without Acura AKI | No intervention | –The group without Acura AKI will be managed based on standard medical procedures. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 20 years old
- Admitted to adult ICU
- Hospital stay of more than 30 hours
Key exclusion criteria (7 listed)
- Known to have acute kidney injury at enrollment
- Currently undergoing hemodialysis treatment
- No available blood or urine test data
- Pregnant women
- HIV-positive patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acura AKIWhen 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 | Device | With Acura AKI |
Primary outcome
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.
6 secondary outcomes
Percentage of recommendations implemented by the primary care team.
Time frame: 24 hours after Randomization
Dialysis rate
Time frame: Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization)
Mortality rate
Time frame: Assessed from time of randomization to date of death from any cause, within 14 days of randomization
Length of hospital stay
Time frame: Assessed from time of randomization to date of hospital discharge, assessed up to 30 days
Change in treatment costs
Time frame: Assessed from time of randomization to 60 days post hospital discharge date, accessed up to 90 days
Long term dialysis
Time frame: From hospital discharge date up to 90 days post discharge date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Te Huang principal investigator
Taichung Veterans General Hospital (TCVGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acura AKI in people with Acute Kidney Injury and Intensive Care, run by Huede Healthtech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Te Huang (+8864-23592525 ext. 3169, huangchunte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (AKI) incidence (time frame: Assessed from time of randomization to time of AKI occurrence (within 7 days post randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.