Drug-Targeted Alerts for Acute Kidney Injury

NCT02771977 | Completed Results DMC

• 2 other identifiers: 20000257861R01DK113191-01A1
• Study Type: interventional
• Target: 5,060
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial, patients with acute kidney injury who have recently received a drug that may affect kidney function will be randomized to having an alert placed in the electronic health record or usual care.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Progression of AKI OR Dialysis OR Death

  Progression of AKI is defined by an increase in KDIGO creatinine stage from time of randomization to the present. Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital records.

  14 days from Randomization

Secondary Outcomes (13)

• Percentage of Patients for Whom Any One of the Targeted Medications is Discontinued

  Assessed within 24 hours from randomization

• 14- Day Mortality Rate

  Assessed from date of randomization to date of death from any cause, within 14 days of randomization

• Inpatient Mortality Rate

  Assessed from point of randomization to the date of death from any cause during the end of current index hospitalization, up to 365 days

• Percentage of Patients Who Receive Dialysis Within 14 Days of Randomization

  Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization

• Percentage of Patients on Inpatient Dialysis

  Assessed from point of randomization to the date of first documented dialysis order during index hospitalization, up to 365 days

Study Arms (2)

Usual Care

NO INTERVENTION

No alert will be fired.

Drug-specific alert

EXPERIMENTAL

A drug-specific AKI alert, including information about the drug of interest as well as the presence of AKI will be fired.

Other: Drug-specific alert

Interventions

Drug-specific alert OTHER

A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.

Drug-specific alert

Eligibility Criteria

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

You may qualify if:

• Acute Kidney Injury based upon the Kidney Disease: Improving Global Outcomes creatinine criteria (a 0.3mg/dl increase over 48 hours or 50% increase over 7 days) and an active order within the past 24 hours to one of the following classes of medications:
• Non-steroidal anti-inflammatory drug
• Renin Angiotensin Aldosterone System Antagonists
• Proton Pump Inhibitors

You may not qualify if:

• Dialysis order prior to AKI onset
• Previous randomization
• Admission to a hospice service or CMO
• First hospital creatinine \>=4.0 mg/dl
• ESKD diagnosis code
• Kidney transplant within six months prior to randomization

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (3)

• Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogenous effect of automated alerts on mortality. J Am Med Inform Assoc. 2025 Dec 25:ocaf222. doi: 10.1093/jamia/ocaf222. Online ahead of print.

  PMID: 41445428 DERIVED

• Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogeneous Effect of Automated Alerts on Mortality. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333302. doi: 10.1101/2025.08.11.25333302.

  PMID: 40832403 DERIVED

• Wilson FP, Yamamoto Y, Martin M, Coronel-Moreno C, Li F, Cheng C, Aklilu A, Ghazi L, Greenberg JH, Latham S, Melchinger H, Mansour SG, Moledina DG, Parikh CR, Partridge C, Testani JM, Ugwuowo U. A randomized clinical trial assessing the effect of automated medication-targeted alerts on acute kidney injury outcomes. Nat Commun. 2023 May 17;14(1):2826. doi: 10.1038/s41467-023-38532-3.

  PMID: 37198160 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Limitations include the fact that only three medication classes were targeted, that this trial was randomized at the patient level, which introduces the possibility of contamination, that it was conducted within a single health system, potentially limiting generalizability, that alert fatigue may have diminished alert performance as it was displayed in competition with all other alerts, and that the language of the alert was limited in how stringently it could recommend medication cessation.

Results Point of Contact

• Title: F. Perry Wilson
• Organization: Yale University

francis.p.wilson@yale.edu

203-737-1704

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 13, 2016
• Study Start: August 24, 2020
• Primary Completion: December 20, 2021
• Study Completion: January 4, 2022
• Last Updated: February 15, 2024
• Results First Posted: June 29, 2023

Record last verified: 2024-02

Locations

US (1)