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

Acute Kidney Injury Clinical Trial

— MEnD-AKI  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06264752
• Other study ID #: STUDY20120008
• Secondary ID: R01DK121730
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

Researchers will randomize 39 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 ≥200% 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 625
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Physician-subject Inclusion

• 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:

Physician-subject Exclusion

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Florida, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 200 percent of reference at the earliest of hospital discharge or 30 days from study enrollment, whichever occurs first.	up to 30 days
Secondary	Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge	Percentage of high-risk patients without AKI at the time of a first level B alert who subsequently progress to maximum AKI severity stages 1, 2, or 3 before hospital discharge or 30 days, whichever comes first.; Percentage of high-risk patients diagnosed with stage-1 AKI at the time of a level B alert who subsequently progress to maximum severity stages 2 or 3 AKI before hospital discharge or 30 days, whichever comes first.; Percentage of high-risk patients diagnosed with stage-2 AKI at the time of a level B alert who subsequently progress to maximum severity stage 3 AKI before hospital discharge or 30 days, whichever comes first.	up to 30 days
Secondary	AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3	AKI intensity rate (per 100 exposed patient-days) calculated as: number of days patients have AKI/ total number of AKI exposed patient-days standardized per 100 exposed days	up to 30 days
Secondary	Nephrotoxic burden	Drug.days* in both study arms for those drugs considered possible/probable, probable and definitely related to AKI in adult, non-ICU patients.; *Drug.days calculation: each drug and each day of therapy increases the burden by 1 drug.day.	up to 30 days