Drug-Targeted Alerts for Acute Kidney Injury

  • STATUS
    Recruiting
  • End date
    Sep 25, 2023
  • participants needed
    5000
  • sponsor
    Yale University
Updated on 25 January 2021
aldosterone
nephropathy
renal injury

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.

Description

Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.

The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.

This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. Alerting will be targeted to three specific drug classes: Non-steroidal Anti-inflammatory drugs, Renin/Angiotensin Blockers, and Proton-Pump inhibitors.

Details
Condition Renal Failure, Acute renal failure, Kidney Failure (Pediatric), Kidney Failure, acute kidney injury, acute kidney injuries
Treatment Drug-specific alert
Clinical Study IdentifierNCT02771977
SponsorYale University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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