Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945241
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Erin Barreto, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Methicillin-resistant Staphylococcus Aureus Sepsis Critical Illness Drug: Vancomycin Other: Cystatin C dosing algorithm Other: Creatine clearance dosing algorithm Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults
Study Start Date : April 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine

Arm Intervention/treatment
Experimental: 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.
Drug: Vancomycin
Intravenous
Other Name: Vancocin

Other: Cystatin C dosing algorithm
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.
Drug: Vancomycin
Intravenous
Other Name: Vancocin

Other: Creatine clearance dosing algorithm
Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute
Other Name: Cockcroft-Gault




Primary Outcome Measures :
  1. Vancomycin target trough achievement [ Time Frame: Baseline ]
    The percentage of initial steady state troughs within the target range.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945241


Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Erin Frazee, PharmD, RPh Mayo Clinic

Publications:
Layout table for additonal information
Responsible Party: Erin Barreto, Assistant Professor of Pharmacy and Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02945241     History of Changes
Other Study ID Numbers: 14-002808
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vancomycin
Critical Illness
Disease Attributes
Pathologic Processes
Cystatins
Anti-Bacterial Agents
Anti-Infective Agents
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action