Trials Today

BLOOM: Pragmatic Feasibility Trial

Purpose

The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.

Conditions

Sepsis
Infection

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Adults ≥18 years of age - Admitted to one of the ICUs at the study center - Prescribed cefepime therapy by the care team

Exclusion Criteria

Individuals will be those with a cephalosporin allergy - Received >1 dose of cefepime in the 24 hours before ICU admission - Transferred from an external hospital without compatible EHR - Does not have a cystatin C and a creatinine available for drug dosing - Acute kidney injury stage 2 or higher - Receiving renal replacement therapy - Treated with extracorporeal membrane oxygenation - Undergoing molecular adsorbent recirculating therapy at the time of beta-lactam initiation - Pregnant - Incarcerated - Declined Minnesota research authorization

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Up-front individualized dosing algorithm	Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.	Other: Up-front individualized dosing algorithm An individualized cefepime dosing algorithm will be used to determine the cefepime dose and interval. The dose recommendation will be provided using the EHR-prompts to the clinical care team and ordered and/or verified by the ICU pharmacist using an established collaborative practice agreement. As a pragmatic trial, at any point care teams may modify the empiric or subsequent dose based on their clinical judgement.
Active Comparator Usual Care	The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr.	Other: Usual Care The standard of care group will receive empiric dosing guided by an institutional antimicrobial guide. Cefepime is typically dosed at 0.5-2 g every 8-24 h according to categorical thresholds of estimated creatinine clearance (eGFRcr). Cystatin C and eGFRcr-cys can be calculated and used at clinicians' discretion to aid in drug dose determination.

Recruiting Locations

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905

Contact:
Gerald W. Flaby Jr., LRT, RRT
507-422-3462
flaby.gerald@mayo.edu

More Details

NCT ID: NCT07287332
Status: Recruiting
Sponsor: Mayo Clinic

Study Contact

Gerald W. Flaby Jr., LRT, RRT
507-422-3462
flaby.gerald@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.