Speaker
Edward Qian, MD, MSc
Assistant Professor of Medicine
Vanderbilt University Medical Center
Division of Pulmonary and Critical Care Medicine
Keywords
ACORN, Antibiotics, Acute Kidney Injury, Critical Care Medicine, Randomized Clinical Trial, EHR
Key Points
- Sepsis is a common cause of critical illness and death. A common treatment is treating with vancomycin plus either piperacillin-tazobactam or cefepime. Piperacillin-tazobactam and cefepime have unique risk/benefit profiles but comparative data are lacking.
- There have been associations with piperacillin and acute kidney injury (AKI). Acute kidney injury is associated with a 6-to-8-fold increase in mortality in critically ill patients. There was concern that there is an association between concurrent vancomycin and piperacillin-tazobactam with creatinine elevations, but a retrospective, observational analysis was inconclusive.
- The ACORN Trial was randomized clinical trial to understand the effect of empiric antibiotic choice for patients in the ED and ICU. The trial enrolled 2,511 patients, who were adults who were in the hospital ED or ICU for less than 12 hours and received at least one dose of empiric cefepime or piperacillin-tazobactam. The intervention was a choice of empiric gram-negative antibiotic (cefepime or piperacillin-tazobactam).
- The screening process was done via an interruptive alert in the electronic health record (EHR) that was activated based on a provider placing an order for drugs. The alert would remind for exclusion criteria, and ask if the patient is eligible for ACORN trial.
- The trial operated under a waiver of informed consent. The research involved no more than minimal risk to subjects, and the research could not be carried out practicably without the waiver or alteration.
- The participant randomization happened within the EHR. The delivery of the intervention happened in the EHR, starting with an alert to enroll. Providers were sent an order set depending on the arm. The study team monitored for compliance within the EHR.
- The primary outcome was AKI ordinate scale between enrollment and Day 14. Secondary outcomes were major adverse kidney events within 14 days and days alive and free of delirium and coma to day 14.
- The trial found that, compared to cefepime, piperacillin-tazobactam does not increase the incidence of AKI. Compared to piperacillin-tazobactam, cefepime may decrease the number of days alive and free of delirium and coma.
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Discussion Themes
-How much pilot testing did you do? I was trained as an EPIC physician builder. In preparation for this trial, I underwent this training so all the pieces that you saw, I built and tested in a relatively short time period.
–How did you engage clinicians and make sure the question you were answering was one they wanted the answer to? There was a huge amount of leg work to engage stakeholders. We were talking to the leadership of ICU, nephrology, ID, and others for buy-in, to answer questions, and to make modifications based on suggestions.
–How portable are your EHR modifications? In particular, how big a lift would it have been to implement the same protocol in multiple EPIC installations? This whole trial was done while I was getting a master’s in applied informatics. The answer is no. The screening and randomization could be portable. Each installed EPIC has slight differences and quirks. There will be small differences in the application of the intervention.
Tags
#pctGR, @Collaboratory1