Acute Kidney InjuryNCT02786277
Learning Alerts for Acute Kidney Injury
A study testing Alert in people with Acute Kidney Injury, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether the use of uplift (also known as Conditional Average Treatment Effect - CATE) modeling to empirically identify patients expected to benefit the most from AKI alerting and to target AKI alerts to these patients will reduce the rates of AKI progression… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,046 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 3 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Admitted to a participating hospital
- Has AKI as defined by creatinine criteria:
- 0.3 mg/dl increase in inpatient serum creatinine over 48 hours OR
- 50% relative increase in inpatient serum creatinine over 7 days
Who cannot join
- Dialysis order prior to AKI onset
- Initial creatinine ≥ 4.0 mg/dl
- Prior admission in which patient was randomized
- Admission to hospice service or comfort measures only order
- ESKD diagnosis code
- Kidney transplant within six months
- Opted out of electronic health record research
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Uplift Modeling to More Narrowly Target Alerts for Acute Kidney Injury
The primary objective of this study is to determine whether the use of uplift (also known as Conditional Average Treatment Effect - CATE) modeling to empirically identify patients expected to benefit the most from AKI alerting and to target AKI alerts to these patients will reduce the rates of AKI progression, dialysis, and mortality.
Read the detailed description
Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients, but despite its association with poor clinical outcomes, AKI is asymptomatic and frequently overlooked by clinicians, with fewer than half of all AKI patients with documentation of the syndrome in the electronic medical record, which was associated with decreased rates of AKI clinical best practices.
Our research group recently conducted a large-scale multicenter randomized controlled trial of electronic alerts for AKI throughout the Yale New Haven Health System from 2018 to 2020 (ELAIA-1). Our study showed that, overall, alerting physicians to the presence of AKI did not demonstrate a difference in the rate of our primary outcome of progression of AKI, dialysis, or death, despite the alert leading to some process of care changes such as measurement of creatinine and urinalysis. There was, however, substantial heterogeneity among the study sites. The proliferation of alerting systems that are ineffective can lead to the phenomenon of alert fatigue, whereby providers tend to ignore alerts in a high-alert environment, and can have deleterious effects on patient care. Further, given the highly heterogenous nature of AKI, a more personalized approach to AKI alerting may be warranted.
Uplift modeling, commonly used in marketing, is a novel concept in the medical field and aims to determine phenotypic characteristics that predict a response (benefit or harm) to a given intervention. In this way, patients who are predicted to benefit most from an intervention are identified and preferentially targeted. Uplift modeling of alerting systems has the potential to both improve alert effectiveness through intelligent targeting, and reduce alert fatigue.
In this study, we will expand upon our prior AKI alert trial to determine prospectively whether the use of uplift modeling to preferentially target patients expected to benefit from an AKI alert will reduce the rates of AKI progression, dialysis and death among hospitalized patients with AKI. Inpatients at 4 teaching hospitals within the YNHH system with AKI, based on the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria, will be randomized to a "recommended" group (with higher scores receiving alerts and lower scores not receiving alerts as recommended) versus an "anti-recommended" group (with higher scores not receiving alerts and lower scores receiving alerts as anti-recommended). The primary outcome will be a composite of AKI progression, dialysis, or mortality within 14 days of randomization. Secondary outcomes will focus on AKI-specific process measures.
- Conditions
- Acute Kidney Injury
- Being tested
- Alert
- 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.
AlertOther
An alert informing the provider of the presence of acute kidney injury will be fired.
| Study group | Role | What they receive |
|---|---|---|
| Recommended | Experimental | Those whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. Receives: Other: Alert |
| Anti-recommended | Experimental | Those whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. Receives: Other: Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Progression to a Higher Stage of AKI OR Dialysis OR Death
Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method.
Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included.
Mortality will be determined from hospital administrative records.
Measured: Within 14 days from randomization
Secondary outcomes (12)
14-day Mortality
Proportion of patients who expire from any cause
Measured: Assessed from point of randomization to date of death within 14 days of randomization
Inpatient Mortality
Proportion of patients who expire from any cause
Measured: Assessed from point of randomization to date of death from any cause, up to one year post-randomization
14-day Dialysis
Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis)
Measured: Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization
Inpatient Dialysis
Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis)
Measured: Assess from point of randomization to date of first documented dialysis order during index hospitalization, up to one year post-randomization
Discharge on Dialysis
Assessed as active orders for dialysis at point of discharge from index hospitalization
Measured: Assessed at point of discharge from index hospitalization, up to one year post-randomization
Progression to Stage 2 AKI
Progression to Stage 2 AKI is defined as a doubling of serum creatinine between randomization and 14 days post randomization, and is considered a worsening of AKI.
Measured: Assessed from the date of randomization to 14 days post randomization
Progression to Stage 3 AKI
Progression to Stage 3 AKI is defined as a tripling of serum creatinine between the date of randomization and 14 days post randomization, and is considered a worsening of AKI.
Measured: Assessed from the date of randomization to 14 days post randomization
Duration of AKI
Defined as the time in hours between AKI onset and AKI cessation during index hospitalization
Measured: Assessed from the date of randomization to the cessation of AKI during index hospitalization, up to one year
30 Day Readmission Rate
Proportion of patients with readmission within 30 days of index hospitalization discharge
Measured: Assessed from discharge date of index hospitalization to 30 days post discharge date
Index Hospitalization Cost
Total cost of index hospitalization
Measured: Assessed from point of randomization to date of discharge from index hospitalization, up to one year
Chart Documentation of AKI
Proportion of patients with chart documentation of AKI as assessed by post-discharge ICD-10 codes
Measured: Assessed from date of randomization to date of discharge from index hospitalization, up to one year
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Contrast administration (de novo order of IV contrast agent within 24 hours of randomization), fluid administration (within 24 hours of randomization), aminoglycoside administration (de novo order within 24 hours of randomization), NSAID administration/cessation (de novo order or cessation of order/absence of de novo order of NSAID within 24 hours of randomization), ACE inhibitor administration/cessation, urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization. Each metric is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.
Measured: 24 hours from randomization to discharge, up to one year post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start15 Feb 2024
- Primary completion14 Aug 2024
- Study completion3 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis P Wilson, MD MSCE, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786277
- Sponsor's protocol ID
- YALEAKIALERTLEARN
- Other IDs
- 1R01DK113191-01A1
- Status last verified
- Sep 2025
- First submitted
- 13 May 2016
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data underlying results for publication will be made available upon publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uplift Modeling to More Narrowly Target Alerts for Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02786277
- Acronym / sponsor ID
- YALEAKIALERTLEARN
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,046 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 3 May 2025 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether the use of uplift (also known as Conditional Average Treatment Effect - CATE) modeling to empirically identify patients expected to benefit the most from AKI alerting and to target AKI alerts to these patients will reduce the rates of AKI progression, dialysis, and mortality.
Detailed description
Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients, but despite its association with poor clinical outcomes, AKI is asymptomatic and frequently overlooked by clinicians, with fewer than half of all AKI patients with documentation of the syndrome in the electronic medical record, which was associated with decreased rates of AKI clinical best practices.
Our research group recently conducted a large-scale multicenter randomized controlled trial of electronic alerts for AKI throughout the Yale New Haven Health System from 2018 to 2020 (ELAIA-1). Our study showed that, overall, alerting physicians to the presence of AKI did not demonstrate a difference in the rate of our primary outcome of progression of AKI, dialysis, or death, despite the alert leading to some process of care changes such as measurement of creatinine and urinalysis. There was, however, substantial heterogeneity among the study sites. The proliferation of alerting systems that are ineffective can lead to the phenomenon of alert fatigue, whereby providers tend to ignore alerts in a high-alert environment, and can have deleterious effects on patient care. Further, given the highly heterogenous nature of AKI, a more personalized approach to AKI alerting may be warranted.
Uplift modeling, commonly used in marketing, is a novel concept in the medical field and aims to determine phenotypic characteristics that predict a response (benefit or harm) to a given intervention. In this way, patients who are predicted to benefit most from an intervention are identified and preferentially targeted. Uplift modeling of alerting systems has the potential to both improve alert effectiveness through intelligent targeting, and reduce alert fatigue.
In this study, we will expand upon our prior AKI alert trial to determine prospectively whether the use of uplift modeling to preferentially target patients expected to benefit from an AKI alert will reduce the rates of AKI progression, dialysis and death among hospitalized patients with AKI. Inpatients at 4 teaching hospitals within the YNHH system with AKI, based on the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria, will be randomized to a "recommended" group (with higher scores receiving alerts and lower scores not receiving alerts as recommended) versus an "anti-recommended" group (with higher scores not receiving alerts and lower scores receiving alerts as anti-recommended). The primary outcome will be a composite of AKI progression, dialysis, or mortality within 14 days of randomization. Secondary outcomes will focus on AKI-specific process measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommended | Experimental | Other: AlertThose whose uplift score represents a probability of benefit greater than 0.5 will generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will not generate an alert. |
| Anti-recommended | Experimental | Other: AlertThose whose uplift score represents a probability of benefit greater than 0.5 will not generate an alert, while those whose uplift score represents a probability of benefit less than 0.5 will generate an alert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years
- Admitted to a participating hospital
- Has AKI as defined by creatinine criteria:
Key exclusion criteria (7 listed)
- Dialysis order prior to AKI onset
- Initial creatinine ≥ 4.0 mg/dl
- Prior admission in which patient was randomized
- Admission to hospice service or comfort measures only order
- ESKD diagnosis code
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 |
|---|---|---|
| AlertAn alert informing the provider of the presence of acute kidney injury will be fired. | Other | Anti-recommended, Recommended |
Primary outcome
Proportion of Patients With Progression to a Higher Stage of AKI OR Dialysis OR Death
Time frame: Within 14 days from randomization
Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method. Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital administrative records.
12 secondary outcomes
14-day Mortality
Time frame: Assessed from point of randomization to date of death within 14 days of randomization
Inpatient Mortality
Time frame: Assessed from point of randomization to date of death from any cause, up to one year post-randomization
14-day Dialysis
Time frame: Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization
Inpatient Dialysis
Time frame: Assess from point of randomization to date of first documented dialysis order during index hospitalization, up to one year post-randomization
Discharge on Dialysis
Time frame: Assessed at point of discharge from index hospitalization, up to one year post-randomization
Progression to Stage 2 AKI
Time frame: Assessed from the date of randomization to 14 days post randomization
Progression to Stage 3 AKI
Time frame: Assessed from the date of randomization to 14 days post randomization
Duration of AKI
Time frame: Assessed from the date of randomization to the cessation of AKI during index hospitalization, up to one year
30 Day Readmission Rate
Time frame: Assessed from discharge date of index hospitalization to 30 days post discharge date
Index Hospitalization Cost
Time frame: Assessed from point of randomization to date of discharge from index hospitalization, up to one year
Chart Documentation of AKI
Time frame: Assessed from date of randomization to date of discharge from index hospitalization, up to one year
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Time frame: 24 hours from randomization to discharge, up to one year post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data underlying results for publication will be made available upon publication of results.
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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. This study is not recruiting at the moment.
Francis P Wilson, MD MSCE principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert in people with Acute Kidney Injury, run by Yale University at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 8 Oct 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Progression to a Higher Stage of AKI OR Dialysis OR Death (time frame: Within 14 days from 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 8 Oct 2025.