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

Primary Purpose

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin continuous infusion
Vancomycin intermittent dosing interval
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with suspected infection
  • Calculated creatinine clearance > 60ml/min

Exclusion Criteria:

  • Age < 18 years
  • Allergic to vancomycin
  • Calculated creatinine clearance < 60ml/min
  • Pregnant
  • Vancomycin administration more than 8 hour and less than 24 hour prior to study enrollment
  • Anticipated vancomycin treatment less than 2 days for surgical prophylaxis

Sites / Locations

  • MGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vancomycin with continuous infusion

Vancomycin with intermittent dose interval

Arm Description

24 hours continuous infusion

infusion rate 1000mg/hr

Outcomes

Primary Outcome Measures

Number of Participants Who Achieved the Target Vancomycin Concentration
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

Secondary Outcome Measures

Time Required to Reach the Therapeutic Levels
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Vancomycin Concentration at 24 Hours
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

Full Information

First Posted
February 4, 2013
Last Updated
May 5, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01786161
Brief Title
Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
Acronym
CIV
Official Title
Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection. Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.
Detailed Description
Early administration of effective antibiotics is the cornerstone of management in septic patients; however, altered pharmacokinetics in critically ill patients has lead to subtherapeutic antibiotic exposure with standard antibiotic dosing and administration. This is further evidenced by low therapeutic target achievement with our intermittent vancomycin dosing nomogram. Administering vancomycin by continuous infusions may lead to achieving a therapeutic concentration and AUC24 more quickly than the administration by intermittent infusions as well as provide a more consistent concentration throughout the dosing period. Therefore, a new vancomycin continuous infusion nomogram was developed to increase the achievement of a goal vancomycin concentration within 24 hours. We hypothesized that vancomycin administered as continuous infusion would achieve the therapeutic target sooner and more consistently than when administered as an intermittent infusion in critically ill surgical patients. The aims of this study were to determine the dosing differences between continuous (CIV) and intermittent (IIV) dosing in critically ill surgical intensive care unit (SICU) patients with preserved renal function and whether calculated Cockcroft-Gault Creatinine Clearance (CG CrCL) or measured creatinine clearance (CrCL) is a better predictor of vancomycin clearance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MRSA - Methicillin Resistant Staphylococcus Aureus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin with continuous infusion
Arm Type
Experimental
Arm Description
24 hours continuous infusion
Arm Title
Vancomycin with intermittent dose interval
Arm Type
Active Comparator
Arm Description
infusion rate 1000mg/hr
Intervention Type
Drug
Intervention Name(s)
Vancomycin continuous infusion
Intervention Description
Vancomycin 24 hour intravenous continuous infusion
Intervention Type
Drug
Intervention Name(s)
Vancomycin intermittent dosing interval
Intervention Description
Vancomycin intravenous infusion at rate 1000mg/hr
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved the Target Vancomycin Concentration
Description
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time Required to Reach the Therapeutic Levels
Description
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Time Frame
as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)
Title
Vancomycin Concentration at 24 Hours
Description
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with suspected infection Calculated creatinine clearance > 60ml/min Exclusion Criteria: Age < 18 years Allergic to vancomycin Calculated creatinine clearance < 60ml/min Pregnant Vancomycin administration more than 8 hour and less than 24 hour prior to study enrollment Anticipated vancomycin treatment less than 2 days for surgical prophylaxis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin Lin, PharmD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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