New Haven, Connecticut 06510

  • Acute Kidney Injury

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02771977


Primary Contact:

Francis P Wilson, MD MSE
Phone: 2037371704
Email: francis.p.wilson@yale.edu


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06510
United States

Francis P Wilson, MD MSCE
Email: francis.p.wilson@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.