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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Up-front individualized dosing algorithm | Experimental | Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight. |
|
| Usual Care | Active Comparator | The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Up-front individualized dosing algorithm | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients screened who qualified for the study | Number of patients who quality for the study out of total number of patients screened, reported as a percentage | 1 year or once the sample size is achieved |
| Distribution of qualified patients across care teams | Number of patients from each ICU care team who qualify for the study | 1 year or once the sample size is achieved |
| Adherence to dosing recommendations | Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage | 1 year or once the sample size is achieved |
| Measure | Description | Time Frame |
|---|---|---|
| Number of antibiotic-free days | Number of antibiotic-free days for the first 28 days | 28-days |
| ICU length of stay | Number of days of initial ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerald W. Flaby Jr., LRT, RRT | Contact | 507-422-3462 | flaby.gerald@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erin Barreto, PharmD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40013864 | Background | Barreto EF, Scheetz MH, Chang J, Cole KC, Fogelson LA, Paul J, Jannetto PJ, Gajic O, Rule AD; Beta Lactam Optimization and Outcomes Management (BLOOM) Study Group. Cystatin C-Guided Dosing Nomogram Improves Target Attainment for Cefepime in the Critically Ill. Crit Care Med. 2025 Apr 1;53(4):e941-e952. doi: 10.1097/CCM.0000000000006622. Epub 2025 Feb 27. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D012772 | Shock, Septic |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Usual Care | Other | 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. |
|
| 1 year |
| Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance | New anti-Pseudomonal beta-lactam resistance which develops within the 6 months following initial treatment | 6 months |
| Proportion of patients who experience clinical success | Complete or partial resolution of clinical signs and symptoms attributed to infection across 8 days of therapy. | 8 days |
| Proportion of patients who experience microbiologic success | Presumed or documented eradication of causative microorganisms | 8 days |
| Mortality | All cause death | 28-days |
| D012769 | Shock |
| D020969 | Disease Attributes |