Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
Condition: Sepsis; AKI; Neurotoxicity
MeSH terms: Neurotoxicity Syndromes
Intervention: anti-pseudomonal cephalosporin; anti-pseudomonal penicillin
Intervention description: Providers will be prompted to order an anti-pseudomonal cephalosporin, such as cefepime with a dose range of 500 mg, 1,000 mg, or 2,000 mg, and frequency every 6, 8, 12, or 24 hours based on provider discretion.; Providers will be prompted to order anti-pseudomonal penicillin, such as piperacillin-tazobactam with a dose range of 3.375 g or 4.5 g and frequency every 6, 8, or 12 hours based on provider discretion.
Intervention MeSH terms: Penicillins; Cephalosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be performed as a pragmatic, randomized controlled clinical trial with parallel group assignment.
Masking: Single (Outcomes Assessor)
Masking description: Patients and providers will necessarily be unblinded, but outcomes will be analyzed by a blind assessor.
Enrollment: 2634.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Sepsis is one of the most common causes of acute illness and death in the United States.
      Early, empiric broad-spectrum antibiotics are a mainstay of sepsis treatment. Two classes of
      antibiotics with activity against Pseudomonas, anti-pseudomonal cephalosporins and
      anti-pseudomonal penicillins, are commonly used for acutely ill adults with sepsis in current
      practice. Recent observational studies, however, have raised concern that anti-pseudomonal
      penicillins may cause renal toxicity. Anti-pseudomonal cephalosporins, by comparison, may be
      associated with a risk of neurotoxicity. Rigorous, prospective data regarding the comparative
      effectiveness and toxicity of these two classes of medications among acutely ill patients are
      lacking. The investigator propose a randomized trial comparing the impact of anti-pseudomonal
      cephalosporins and anti-pseudomonal penicillins on renal outcomes of acutely ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years old

          -  Located in a participating emergency department or medical intensive care unit

          -  Less than 12 hours from presentation to study hospital

          -  Treating clinician initiating an order for an anti-pseudomonal cephalosporin or
             anti-pseudomonal penicillin

        Exclusion Criteria:

          -  Known receipt of > 1 dose of an anti-pseudomonal cephalosporin or anti-pseudomonal
             penicillin during the last 7 days

          -  Current documented allergy to cephalosporins or penicillin

          -  Known to be a prisoner

          -  Treating clinicians feel that either an anti-pseudomonal cephalosporin or
             anti-pseudomonal penicillin is required or contraindicated for the optimal treatment
             of the patient, including for more directed antibiotic therapy against known prior
             resistant infections or suspected sepsis with an associated central nervous system
             infection