Clinical trial NCT02945241: Cystatin-C C-guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project
Official title: Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methicillin-resistant Staphylococcus Aureus
Sepsis
Critical Illness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vancomycin target trough achievement
timeFrame: Baseline
Secondary outcomes:
measure: Length of stay (hospital and ICU)
timeFrame: Baseline
measure: Acute kidney injury (AKI) and renal replacement therapy
timeFrame: 7-days
measure: Treatment failure
timeFrame: 7-days
measure: Infection recurrence
timeFrame: 28-days
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Erin Frazee, PharmD, RPh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frazee EN, Rule AD, Herrmann SM, Kashani KB, Leung N, Virk A, Voskoboev N, Lieske JC. Serum cystatin C predicts vancomycin trough levels better than serum creatinine in hospitalized patients: a cohort study. Crit Care. 2014 May 29;18(3):R110. doi: 10.1186/cc13899.