Level A
OtherPharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.
NCT Number: NCT06264752
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
UPMC Altoona, Altoona, Pennsylvania, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Physician-subject Inclusion
Patient-subject Inclusion
Exclusion criteria
Physician-subject Exclusion
Patient-subject Exclusion
Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.
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 Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management.
Time frame: up to 30 days
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.
Time frame: up to 30 days
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.
Time frame: up to 30 days
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
Time frame: up to 30 days
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.
University of Pittsburgh
Other
Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)
Acronym: MEnD-AKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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