NCT02945241

Cystatin-C C-guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project

Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Methicillin-resistant Staphylococcus Aureus
• Sepsis
• Critical Illness

Interventions

Type	Name	Description
DRUG	Vancomycin	Intravenous
OTHER	Cystatin C dosing algorithm	Expressed in milliliters per minute
OTHER	Creatine clearance dosing algorithm	Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-06-01
• Completion: 2016-03-01
• First posted: 2016-10-26
• Last updated: 2023-10-10