Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury
NCT ID: NCT06264752
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
698 participants
INTERVENTIONAL
2024-02-15
2025-07-15
Brief Summary
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Detailed Description
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The primary outcome is Major Adverse Kidney Events within 30 days of randomization (MAKE30), defined as defined as a composite of death, new kidney replacement therapy, or final serum creatinine ≥150% of reference at the earliest of hospital discharge or 30 days from study enrollment, whichever occurs first. Key secondary outcomes include: progression of AKI from time of Level B intervention (first alert generated) to hospital discharge, AKI intensity (duration of AKI by all stages, duration of AKI stage 2, and duration of AKI stage 3), and nephrotoxic burden.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention.
Study Groups
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Protocolized stage-based intervention
The intervention uses an automated alerting system to identify patients: 1) receiving a high-risk drug or drug combination associated with AKI and at low-risk for progression to either stage 2 AKI or stage 3 AKI (Level A) and 2) patients without AKI or stage 1 AKI receiving a high-risk drug or drug combination associated with AKI and at high risk for progression to either stage 2 AKI or stage 3 AKI, and patients with AKI stage 2 or stage 3 receiving a high-risk drug or drug combination associated with AKI or a medication that requires renal dose adjustment (Level B). This patient specific risk-profile will be coupled with recommendations for medication management and delivered to the physician by a pharmacist for consideration and approval.
Level A
Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.
Level B
The pharmacist will make nephrotoxic/renally eliminated medication management recommendations to the attending physician (or designee). Recommendations may include stopping or changing a drug, changing dose or schedule, ordering laboratory tests, taking no action, or other. The pharmacist will record details of the interaction with the physician and whether recommendations were accepted.
Usual Care
A Cerner EMR-based AKI passive alert which is standard of care at UPMC.
Passive Alert
Passive Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management.
Interventions
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Level A
Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.
Level B
The pharmacist will make nephrotoxic/renally eliminated medication management recommendations to the attending physician (or designee). Recommendations may include stopping or changing a drug, changing dose or schedule, ordering laboratory tests, taking no action, or other. The pharmacist will record details of the interaction with the physician and whether recommendations were accepted.
Passive Alert
Passive Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management.
Eligibility Criteria
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Inclusion Criteria
* Physicians employed at UPMC hospital systems
* Attending physicians of record who care for patients across multiple units outside ICU/ED
* Physician cares for 1 or more patient receiving a system alert identifying high-risk for AKI
Patient-subject Inclusion
* System alert identifying risk for AKI
* Patient has attending physician who is participating in the randomized clusters
* After initial patient inclusion, an individual patient will not be eligible for re-inclusion until after 90 days. Re-inclusion will only be allowed if a separate hospital admission/encounter occurs and only starting on day 91
Exclusion Criteria
* Physicians of record who only care for ICU or ED patients
* Physicians who primarily provide care for transplant (heart, kidney, liver, etc.) patients
* Physicians who primarily provide consult services only (dermatology, rehabilitation, etc.)
Patient-subject Exclusion
• Patients with end stage renal disease on admission, baseline eGFR \<15, comfort measures only, or died before the intervention could be delivered
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
University of Pittsburgh Medical Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Sandra Kane-Gill, PharmD, MSc, FCCP, FCCM
Professor of Pharmacy, Department of Pharmacy and Therapeutics
Principal Investigators
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Sandra L Kane-Gill, PharmD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Azra Bihorac, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UPMC Altoona
Altoona, Pennsylvania, United States
UPMC Horizon
Farrell, Pennsylvania, United States
UPMC McKeesport
McKeesport, Pennsylvania, United States
UPMC Jameson
New Castle, Pennsylvania, United States
UPMC Magee
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian/Montefiore
Pittsburgh, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
UPMC Williamsport
Williamsport, Pennsylvania, United States
Countries
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References
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Stottlemyer BA, Kellum JA, Bihorac A, Ozrazgat-Baslanti T, Murugan R, Chang CH, Amatullah N, Tran TL, Lukan CJ, Elder MM, Adiyeke E, Ren Y, Ricketts D, Emanuele B, Rashidi P, Kane-Gill SL. Multi-hospital electronic decision support for drug-associated acute kidney injury (MEnD-AKI): Study protocol for a randomized clinical trial. Contemp Clin Trials. 2025 Oct;157:108055. doi: 10.1016/j.cct.2025.108055. Epub 2025 Aug 22.
Other Identifiers
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STUDY20120008
Identifier Type: -
Identifier Source: org_study_id
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