Skip to main content
OpenTrials
Completed

NCT Number: NCT02945241

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

Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

Intravenous

Other names: Vancocin

Cystatin C dosing algorithm

Other

Expressed in milliliters per minute

Creatine clearance dosing algorithm

Other

Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute

Other names: Cockcroft-Gault

Primary outcomes

  1. Vancomycin target trough achievement

    Time frame: Baseline

    The percentage of initial steady state troughs within the target range.

Secondary outcomes

  1. Length of stay (hospital and ICU)

    Time frame: Baseline

  2. Acute kidney injury (AKI) and renal replacement therapy

    Time frame: 7-days

    New onset AKI, defined as KDIGO stage II or greater AKI, within 48-hours of and within 7-days of vancomycin initiation

  3. Treatment failure

    Time frame: 7-days

    Treatment failure in patients with confirmed gram-positive infection after at least 48-hours of vancomycin therapy and within 7-days

  4. Infection recurrence

    Time frame: 28-days

    New onset of infection within 28-days among patients with confirmed gram-positive infection

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2016
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.