Study Results
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View full resultsBasic Information
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COMPLETED
NA
6030 participants
INTERVENTIONAL
2018-03-26
2020-01-06
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Usual Care
No alert will be fired.
No interventions assigned to this group
Electronic AKI Alert
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.
AKI Alert
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.
Interventions
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AKI Alert
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Francis P Wilson, MD MSCE
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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.
Other Identifiers
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YALEAKIALERT
Identifier Type: OTHER
Identifier Source: secondary_id
1604017596
Identifier Type: -
Identifier Source: org_study_id
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