Acute Kidney InjuryMEnD-AKINCT06264752
Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury
A study testing Level A, Level B and Passive Alert in people with Acute Kidney Injury, run by University of Pittsburgh at 8 sites in United States.
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 near real-time predictive analytics to support a pharmacist-led intervention delivered to attending… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Level A, Level B and Passive Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Feb 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UPMC Altoona
Altoona, Pennsylvania, 16601
UPMC Horizon
Farrell, Pennsylvania, 16121
UPMC McKeesport
McKeesport, Pennsylvania, 15132
UPMC Jameson
New Castle, Pennsylvania, 16105
UPMC Magee
Pittsburgh, Pennsylvania, 15213
UPMC Presbyterian/Montefiore
Pittsburgh, Pennsylvania, 15213
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
UPMC Williamsport
Williamsport, Pennsylvania, 17701
About this study
Official title: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)
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.
Read the 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
- Being tested
- Level A, Level B, Passive Alert
- Keywords
- acute kidney injury, drug-associated acute kidney injury, adverse drug event, pharmacist
- Medical subject headings
- Acute Kidney Injury, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level AOther
Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.
Level BOther
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 AlertOther
Passive Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Level A; Other: Level B |
| Usual Care | Active comparator | A Cerner EMR-based AKI passive alert which is standard of care at UPMC. Receives: Other: Passive Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Secondary outcomes (3)
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.
Measured: up to 30 days
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
Measured: up to 30 days
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.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, University of Pittsburgh Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Sandra Kane-Gill, PharmD, MSc, FCCP, FCCM, University of Pittsburgh
- Investigators
- Sandra L Kane-Gill, PharmD, MS, Principal investigator, University of PittsburghAzra Bihorac, MD, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264752
- Sponsor's protocol ID
- STUDY20120008
- Other IDs
- R01DK121730
- Acronym
- MEnD-AKI
- Status last verified
- Sep 2025
- First submitted
- 8 Feb 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40850370
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)
- ClinicalTrials.gov ID
- NCT06264752
- Acronym / sponsor ID
- MEnD-AKI / STUDY20120008
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, drug-associated acute kidney injury, adverse drug event, pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Florida, University of Pittsburgh Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Protocolized stage-based intervention | Experimental | Other: Level A, Other: Level BThe 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. |
| Usual Care | Active comparator | Other: Passive AlertA Cerner EMR-based AKI passive alert which is standard of care at UPMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level APharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician. | Other | Protocolized stage-based intervention |
| Level BThe 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 | Protocolized stage-based intervention |
| Passive AlertPassive Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management. | Other | Usual Care |
Primary outcome
Major Adverse Kidney Events within 30 days of randomization (MAKE30)
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.
3 secondary outcomes
Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge
Time frame: up to 30 days
AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3
Time frame: up to 30 days
Nephrotoxic burden
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 40850370Stottlemyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra L Kane-Gill, PharmD, MS principal investigator
University of Pittsburgh
Azra Bihorac, MD, MS principal investigator
University of Florida
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level A, Level B and Passive Alert in people with Acute Kidney Injury, run by University of Pittsburgh at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Kidney Events within 30 days of randomization (MAKE30) (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.