NCT06264752

Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury

Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with near real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults.

Detailed description

Researchers will randomize 38 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. The intervention uses an automated alerting system to identify patients: 1) receiving a high-risk drug or drug combination associated with D-AKI and at low-risk for progression to either stage 2 AKI or stage 3 AKI per KDIGO criteria (Level A) and 2) patients without AKI or stage 1 AKI receiving a high-risk drug or drug combination associated with D-AKI and at high risk for progression to either stage 2 AKI or stage 3 AKI per KDIGO criteria, and patients with AKI stage 2 or stage 3 receiving a high-risk drug or drug combination associated with D-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. Additionally, the investigators will assess cost-effectiveness and physicians' perception of the pharmacist-led service. 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

• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	Level A	Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2024-02-20
• Last updated: 2025-09-12

Locations

8 sites across 1 country: United States