NCT02945241

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 24, 2016

Last Update Submit

October 6, 2023

Conditions

Methicillin-resistant Staphylococcus AureusSepsisCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Vancomycin target trough achievement

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

    Baseline

Secondary Outcomes (4)

  • Length of stay (hospital and ICU)

    Baseline

  • Acute kidney injury (AKI) and renal replacement therapy

    7-days

  • Treatment failure

    7-days

  • Infection recurrence

    28-days

Study Arms (2)

Cystatin C-guided vancomycin dosing algorithm

EXPERIMENTAL

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: VancomycinOther: Cystatin C dosing algorithm

Creatinine clearance guided vancomycin dosing

OTHER

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: VancomycinOther: Creatine clearance dosing algorithm

Interventions

VancomycinDRUG

Intravenous

Also known as: Vancocin
Creatinine clearance guided vancomycin dosingCystatin C-guided vancomycin dosing algorithm
Cystatin C dosing algorithmOTHER

Expressed in milliliters per minute

Cystatin C-guided vancomycin dosing algorithm
Creatine clearance dosing algorithmOTHER

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

Also known as: Cockcroft-Gault
Creatinine clearance guided vancomycin dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 24887089BACKGROUND

MeSH Terms

Conditions

SepsisCritical Illness

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Erin Frazee, PharmD, RPh

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pharmacy and Medicine

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

March 1, 2016

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share