Critical Illness, Methicillin-resistant Staphylococcus Aureus, Sepsis
Conditions
Brief summary
Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.
Detailed description
This is a prospective, quality improvement study that evaluated critically ill patients initiated on intravenous vancomycin. Between January 2012 through October 2013, vancomycin was dosed at 15-20mg/kg at an interval guided by creatinine clearance using the Cockcroft Gault equation (control arm). Steady state trough concentrations were assessed prior to the 4th dose of a consistent regimen and compared to the individualized target trough range (10-15mg/L or 15-20mg/L) appropriate for the suspected or documented source of infection. Given low overall trough achievement observed with standard care, a quality improvement project was undertaken. After approval by local clinical practice committees with representation from the Division of Infectious Diseases, Pharmacy and Critical Care, a quality improvement project was undertaken to implement a new vancomycin dosing nomogram with dosing intervals based on the Chronic Kidney Disease Epidemiology Collaborative (CKD-EPI) creatinine-cystatin GFR equation, expressed in mL/min. After structured education was provided, the dosing algorithm was rolled out from December 2013 through May 2015 (intervention arm). Steady state target vancomycin trough achievement was compared between study arms with and without adjustment for potential confounders.
Interventions
DRUGVancomycin
Intravenous
OTHERCystatin C dosing algorithm
Expressed in milliliters per minute
OTHERCreatine clearance dosing algorithm
Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized in one of three intensive care units at Mayo Clinic in Rochester, Minnesota * Suspected or documented gram-positive infection * Prescribed IV vancomycin at a consistent dose and scheduled with 8, 12, or 24 hour Vancomycin dosing interval
Exclusion criteria
* Vulnerable population * Received greater than 1 dose of Vancomycin in the 96 hours before ICU admission * Baseline glomerular filtration rate (GFR) of less than 20 milliliters/minute * Undergoing renal replacement therapy * Body mass index \> 40kg/m2 * Weight \< 40kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vancomycin target trough achievement | Baseline | The percentage of initial steady state troughs within the target range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury (AKI) and renal replacement therapy | 7-days | New onset AKI, defined as KDIGO stage II or greater AKI, within 48-hours of and within 7-days of vancomycin initiation |
| Treatment failure | 7-days | Treatment failure in patients with confirmed gram-positive infection after at least 48-hours of vancomycin therapy and within 7-days |
| Infection recurrence | 28-days | New onset of infection within 28-days among patients with confirmed gram-positive infection |
| Length of stay (hospital and ICU) | Baseline | — |
Outcome results
None listed