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

NCT06264752 | Completed

• 2 other identifiers: STUDY20120008R01DK121730
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acute Kidney Injury

Keywords

acute kidney injury; drug-associated acute kidney injury; adverse drug event; pharmacist

Outcome Measures

Primary Outcomes (1)

• Major Adverse Kidney Events within 30 days of randomization (MAKE30)

  Composite of death, new kidney replacement therapy, or final serum creatinine greater than or equal to 150 percent of reference at the earliest of hospital discharge or 30 days from study enrollment, whichever occurs first.

  up to 30 days

Secondary Outcomes (3)

• Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge

  up to 30 days

• AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3

  up to 30 days

• Nephrotoxic burden

  up to 30 days

Study Arms (2)

Protocolized stage-based intervention

EXPERIMENTAL

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.

Other: Level A; Other: Level B

Usual Care

ACTIVE COMPARATOR

A Cerner EMR-based AKI passive alert which is standard of care at UPMC.

Other: Passive Alert

Interventions

Level A OTHER

Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.

Protocolized stage-based intervention

Level B OTHER

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.

Protocolized stage-based intervention

Passive Alert OTHER

Passive Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• System alert identifying risk for AKI
• Patient has attending physician who is participating in the randomized clusters

You may not qualify if:

• 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.)
• Patients with end stage renal disease on admission, baseline eGFR \<15, comfort measures only, or died before the intervention could be delivered

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Florida: collaborator
• University of Pittsburgh Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (8)

UPMC Altoona

Altoona, Pennsylvania, 16601, United States

Location

UPMC Horizon

Farrell, Pennsylvania, 16121, United States

Location

UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC Jameson

New Castle, Pennsylvania, 16105, United States

Location

UPMC Magee

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Presbyterian/Montefiore

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Williamsport

Williamsport, Pennsylvania, 17701, United States

Location

Related Publications (1)

• 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.

  PMID: 40850370 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chemically-Induced Disorders

Study Officials

• Sandra L Kane-Gill, PharmD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Azra Bihorac, MD, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians performing the analysis will be blinded to the treatment allocation. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacy, Department of Pharmacy and Therapeutics

Model Details: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. 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. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)