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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients

NCT01157533

Infection

TERMINATED NA

Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

NCT02764359

Infection Sepsis Obesity

UNKNOWN NA

Pharmacokinetics of Vancomycin in ICU Patients

NCT02844192

Suspected Infection With Vancomycin Susceptible Bacterial Strains

UNKNOWN

Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients

NCT01786161

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

TERMINATED PHASE4

Pharmacokinetics of Vancomycin in Adults Receiving ECMO

NCT00281281

Extracorporeal Membrane Oxygenation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Methicillin-resistant Staphylococcus Aureus Sepsis Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cystatin C-guided vancomycin dosing algorithm

Cystatin C is an endogenous cysteine proteinase inhibitor produced by all nucleated cells and a biomarker used routinely to estimate glomerular filtration rate either alone or in combination with creatinine. This new dosing algorithm includes patient weight, individualized goal trough concentration, and glomerular filtration rate (expressed with the CKD-EPI creatinine-cystatin C equation in mL/min) to determine dose and frequency.

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Intravenous

Cystatin C dosing algorithm

Intervention Type OTHER

Expressed in milliliters per minute

Creatinine clearance guided vancomycin dosing

Historical controls for the quality improvement project had doses based on weight and interval established with the creatinine clearance using the Cockcroft-Gault equation.

Group Type OTHER

Vancomycin

Intervention Type DRUG

Intravenous

Creatine clearance dosing algorithm

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vancomycin

Intravenous

Intervention Type DRUG

Cystatin C dosing algorithm

Expressed in milliliters per minute

Intervention Type OTHER

Creatine clearance dosing algorithm

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vancocin Cockcroft-Gault

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No