Optimizing Electronic Alerts for Acute Kidney Injury

A study testing AKI Alert in people with Acute Kidney Injury, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set. 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?: AKI Alert
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6,030 participants
Where: 1 siteUnited States
Study dates: 26 Mar 2018to 6 Jan 2020
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

Adult ≥ 18 years admitted to a participating study hospital
Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).

Who cannot join

ESKD diagnosis code
Dialysis order prior to AKI onset
Initial creatinine >=4.0mg/dl
Prior admission in which patient was randomized.
Admission to hospice service or comfort measures only order
Kidney transplant within 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale New Haven Hospital
New Haven, Connecticut, 06520

Other trials in United States

About this study

This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

Read the detailed description

Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.

The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.

This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.

Conditions: Acute Kidney Injury
Being tested: AKI 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.

AKI AlertOther
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.

Study groups in NCT02753751
Study group	Role	What they receive
Usual Care	No intervention	No alert will be fired.
Electronic AKI Alert	Experimental	A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. Receives: Other: AKI Alert

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death
Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of 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.
Mortality will be determined from hospital administrative records.
Measured: 14 days from randomization

Secondary outcomes (8)

Mortality
14-day or inpatient mortality
Measured: 14 days from randomization
Dialysis
14-day, inpatient, or discharged on dialysis
Measured: 14 days from randomization
AKI Progression
Percent of patients who progress to stage 2 AKI and to stage 3 AKI
Measured: 14 days from randomization
AKI Duration
Number of participants with AKI duration of <2 days, 2-<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)
Measured: 14 days from randomization
Readmission Rate
30 day readmission rate
Measured: 30 days from randomization
Index Hospitalization Cost
Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.
Measured: Index hospitalization through discharge, up to one year
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), 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 occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization.
Each metric above 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
Number of Subjects With Chart Documentation of AKI
Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication
Measured: Index hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 20186 Jan 2020

First posted28 Apr 2016 (estimated)
Study start26 Mar 2018
Primary completion6 Jan 2020
Study completion6 Jan 2020

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.
Publications (5)Papers the sponsor has linked to this study.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 6,030 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753751
Sponsor's protocol ID: 1604017596
Other IDs: YALEAKIALERT, 1R01DK113191-01A1
Status last verified: Jan 2022
First submitted: 25 Apr 2016
Last updated: 10 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified aggregate data for the primary and secondary outcomes will be made available.

Publications

Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
PubMed 25726515
Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogenous effect of automated alerts on mortality. J Am Med Inform Assoc. 2026 Mar 1;33(3):653-662. doi: 10.1093/jamia/ocaf222.
PubMed 41445428
Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogeneous Effect of Automated Alerts on Mortality. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333302. doi: 10.1101/2025.08.11.25333302.
PubMed 40832403
Wilson FP, Martin M, Yamamoto Y, Partridge C, Moreira E, Arora T, Biswas A, Feldman H, Garg AX, Greenberg JH, Hinchcliff M, Latham S, Li F, Lin H, Mansour SG, Moledina DG, Palevsky PM, Parikh CR, Simonov M, Testani J, Ugwuowo U. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. BMJ. 2021 Jan 18;372:m4786. doi: 10.1136/bmj.m4786.
PubMed 33461986
Mutter M, Martin M, Yamamoto Y, Biswas A, Etropolski B, Feldman H, Garg A, Gourlie N, Latham S, Lin H, Palevsky PM, Parikh C, Moreira E, Ugwuowo U, Wilson FP. Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale. BMJ Open. 2019 Jun 1;9(5):e025117. doi: 10.1136/bmjopen-2018-025117.
PubMed 31154298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Electronic Alerts for Acute Kidney Injury
ClinicalTrials.gov ID: NCT02753751
Acronym / sponsor ID: 1604017596
Conditions: Acute Kidney Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,030 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 26 Mar 2018 (actual)
Primary completion: 6 Jan 2020 (actual)
Study completion: 6 Jan 2020 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Posted 10 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–No alert will be fired.
Electronic AKI Alert	Experimental	Other: AKI AlertA pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult ≥ 18 years admitted to a participating study hospital
Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).

Key exclusion criteria (6 listed)

ESKD diagnosis code
Dialysis order prior to AKI onset
Initial creatinine >=4.0mg/dl
Prior admission in which patient was randomized.
Admission to hospice service or comfort measures only order

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
AKI AlertProvider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.	Other	Electronic AKI Alert

Primary outcome

Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death
Time frame: 14 days from randomization
Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of 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. Mortality will be determined from hospital administrative records.

8 secondary outcomes

Mortality
Time frame: 14 days from randomization
Dialysis
Time frame: 14 days from randomization
AKI Progression
Time frame: 14 days from randomization
AKI Duration
Time frame: 14 days from randomization
Readmission Rate
Time frame: 30 days from randomization
Index Hospitalization Cost
Time frame: Index hospitalization through discharge, 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
Number of Subjects With Chart Documentation of AKI
Time frame: Index hospitalization

Results and safety

Results posted to the registry on 10 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	2,971	2,971
Electronic AKI Alert	3,059	3,059

Primary outcome: Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death

Time frame: 14 days from randomization. Count of participants. Unit: Participants

Measure	Usual Care n = 2971	Electronic AKI Alert n = 3059
Value	622	653

Usual Care vs Electronic AKI Alert: Risk Ratio (RR): 1.02 (95% CI 0.93 to 1.13), p = 0.67, Cochran-Mantel-Haenszel

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of the study (22 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 2,971 (0%)	0 of 2,971 (0%)	265 of 2,971
Electronic AKI Alert	0 of 3,059 (0%)	0 of 3,059 (0%)	272 of 3,059

Limitations and caveats (from the sponsor): Randomization occurred at the patient level, potentially biasing the results towards the null hypothesis. The alert was largely informational with no patient-specific recommendations. The alert was only sent to certain care providers, notably excluding nurses and pharmacists, who might specifically benefit from receipt of the alert. The alert was conducted across six hospitals within a single large health system in the Northeastern United States, limiting generalizability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25726515Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
Derived from this study: PubMed 41445428Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogenous effect of automated alerts on mortality. J Am Med Inform Assoc. 2026 Mar 1;33(3):653-662. doi: 10.1093/jamia/ocaf222.
Derived from this study: PubMed 40832403Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogeneous Effect of Automated Alerts on Mortality. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333302. doi: 10.1101/2025.08.11.25333302.
Derived from this study: PubMed 33461986Wilson FP, Martin M, Yamamoto Y, Partridge C, Moreira E, Arora T, Biswas A, Feldman H, Garg AX, Greenberg JH, Hinchcliff M, Latham S, Li F, Lin H, Mansour SG, Moledina DG, Palevsky PM, Parikh CR, Simonov M, Testani J, Ugwuowo U. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. BMJ. 2021 Jan 18;372:m4786. doi: 10.1136/bmj.m4786.
Derived from this study: PubMed 31154298Mutter M, Martin M, Yamamoto Y, Biswas A, Etropolski B, Feldman H, Garg A, Gourlie N, Latham S, Lin H, Palevsky PM, Parikh C, Moreira E, Ugwuowo U, Wilson FP. Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale. BMJ Open. 2019 Jun 1;9(5):e025117. doi: 10.1136/bmjopen-2018-025117.
This link is displayed on the alert and is our clinical trial study website. It contains information about the trial, describes AKI best practices, and provides contact information.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified aggregate data for the primary and secondary outcomes will be made available.

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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 AKI 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 2 inclusion and 6 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 10 Feb 2022. 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 10 Feb 2022). 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?

Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death (time frame: 14 days from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02753751, which also lists 5 linked publications.

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 10 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.