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| ID | Type | Description | Link |
|---|---|---|---|
| YALEAKIALERT | Other Identifier | former unique ID | |
| 1R01DK113191-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKI Alert | Other | Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 14-day or inpatient mortality | 14 days from randomization |
| Dialysis | 14-day, inpatient, or discharged on dialysis | 14 days from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis P Wilson, MD MSCE | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25726515 | Background | 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. | |
| 41445428 | Derived | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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De-identified aggregate data for the primary and secondary outcomes will be made available.
Data will be available within one year of completion.
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From 3/29/2018 to 12/14/2019, 6,030 individuals met enrollment criteria and were randomized across 6 hospitals of a single healthcare system.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | No alert will be fired. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | No alert will be fired. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 14 days from randomization |
|
Duration of the study (22 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | No alert will be fired. | 265 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francis P. Wilson | Yale University | 2037376095 | francis.p.wilson@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2020 | Sep 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2020 | Sep 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| AKI Progression | Percent of patients who progress to stage 2 AKI and to stage 3 AKI | 14 days from randomization |
| AKI Duration | Number of participants with AKI duration of <2 days, 2-\ | 14 days from randomization |
| Readmission Rate | 30 day readmission rate | 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. | 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. | 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 | Index hospitalization |
| 40832403 | Derived | 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. |
| 33461986 | Derived | 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. |
| 31154298 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Medical Admission | Count of Participants | Participants |
|
| ICU Patient | Count of Participants | Participants |
|
| ER Patient | Count of Participants | Participants |
|
| Ward Patient | Count of Participants | Participants |
|
| Hospital 1 (Urban, teaching) | Count of Participants | Participants |
|
| Hospital 2 (Urban, teaching) | Count of Participants | Participants |
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| Hospital 3 (Urban, teaching) | Count of Participants | Participants |
|
| Hospital 4 (Suburban, teaching) | Count of Participants | Participants |
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| Hospital 5 (Suburban, non-teaching) | Count of Participants | Participants |
|
| Hospital 6 (Suburban, non-teaching) | Count of Participants | Participants |
|
| Chronic Kidney Disease | Count of Participants | Participants |
|
| Congestive Heart Failure | Count of Participants | Participants |
|
| COPD | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
|
| Malignancy | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Liver Disease | Count of Participants | Participants |
|
| eGFR at admission (ml/min/1.73m2) | Median | Inter-Quartile Range | ml/min/1.73m2 |
|
| Creatinine, mg/dL | Median | Inter-Quartile Range | mg/dL |
|
| Nadir creatinine in 48 hrs prior to randomization, mg/dL | Median | Inter-Quartile Range | mg/dL |
|
| Sodium, meq/L | Median | Inter-Quartile Range | meq/L |
|
| Potassium, meq/L | Median | Inter-Quartile Range | meq/L |
|
| Chloride, meq/L | Median | Inter-Quartile Range | meq/L |
|
| Bicarbonate, meq/L | Median | Inter-Quartile Range | meq/L |
|
| Anion Gap, meq/L | Median | Inter-Quartile Range | meq/L |
|
| Blood Urea Nitrogen, mg/dL | Median | Inter-Quartile Range | mg/dL |
|
| White Blood Cell Count, (cells*1000/ul) | Median | Inter-Quartile Range | cells*1000/uL |
|
| Hemoglobin, g/dL | Median | Inter-Quartile Range | g/dL |
|
| Platelet Count, (cells*1000/ul) | Median | Inter-Quartile Range | cells*1000/ul |
|
| Contrast in prior 72 hours | Count of Participants | Participants |
|
| Cardiothoracic surgery in prior 72 hours | Count of Participants | Participants |
|
| ACE inhibitor/ARB in prior 72 hours | Count of Participants | Participants |
|
| NSAID in prior 72 hours | Count of Participants | Participants |
|
| PPI in prior 72 hours | Count of Participants | Participants |
|
| Time from admission to randomization, hours | Median | Inter-Quartile Range | hours |
|
| Time from AKI to randomization, hours | Median | Inter-Quartile Range | hours |
|
| Unique providers reached | Median | Inter-Quartile Range | Providers |
|
|
|
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| Secondary | Mortality | 14-day or inpatient mortality | Posted | Count of Participants | Participants | 14 days from randomization |
|
|
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| Secondary | Dialysis | 14-day, inpatient, or discharged on dialysis | Posted | Count of Participants | Participants | 14 days from randomization |
|
|
|
| Secondary | AKI Progression | Percent of patients who progress to stage 2 AKI and to stage 3 AKI | Posted | Count of Participants | Participants | 14 days from randomization |
|
|
|
| Secondary | AKI Duration | Number of participants with AKI duration of <2 days, 2-\ | Posted | Count of Participants | Participants | 14 days from randomization |
|
|
|
| Secondary | Readmission Rate | 30 day readmission rate | Data have not yet been collected. | Posted | 30 days from randomization |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | dollars | Index hospitalization through discharge, up to one year |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours from randomization to discharge, up to one year |
|
|
|
| Secondary | 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 | Chart documentation via ICD-10 codes (code N17) have been collected. Documentation via chart adjudication has not yet been collected. | Posted | Count of Participants | Participants | Index hospitalization |
|
|
|
| 2,971 |
| 0 |
| 2,971 |
| 0 |
| 2,971 |
| EG001 | 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. | 272 | 3,059 | 0 | 3,059 | 0 | 3,059 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 7+ days |
|
| Urinalysis |
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| Urine Output Measurement |
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| Subsequent Creatinine Measurement (28 hours) |
|
| Renal Consult (within 14 days) |
|
| Contrast exposure |
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| Aminoglycoside exposure |
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| Aminoglycoside exposure among those already receiving aminoglycoside |
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| NSAID exposure |
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| NSAID exposure among those already receiving NSAIDs |
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| ACE/ARB exposure |
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| ACE/ARB exposure among those already receiving ACE/ARB |
|
| AKI documentation (at end of encounter) |
|