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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945241
• Other study ID #: 14-002808
• Status: Completed
• Phase: Phase 1
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Methicillin-resistant Staphylococcus Aureus
• Sepsis

Intervention

Drug:
• Vancomycin
Intravenous

Other:
• Cystatin C dosing algorithm
Expressed in milliliters per minute
• Creatine clearance dosing algorithm
Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancomycin target trough achievement	The percentage of initial steady state troughs within the target range.	Baseline
Secondary	Length of stay (hospital and ICU)		Baseline
Secondary	Acute kidney injury (AKI) and renal replacement therapy	New onset AKI, defined as KDIGO stage II or greater AKI, within 48-hours of and within 7-days of vancomycin initiation	7-days
Secondary	Treatment failure	Treatment failure in patients with confirmed gram-positive infection after at least 48-hours of vancomycin therapy and within 7-days	7-days
Secondary	Infection recurrence	New onset of infection within 28-days among patients with confirmed gram-positive infection	28-days