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Loading Vancomycin Doses in the Emergency Department (Loaded)

Primary Purpose

Infectious Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Vancomycin
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Disease focused on measuring Vancomycin, Therapeutic Levels, Infectious Disease, Recommendations

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years of age
  • Treated in Christiana Emergency Department
  • Receiving Vancomycin for an infection or presumed infection
  • Being admitted to Christiana Hospital
  • Planned continued use of Vancomycin after admission.

Exclusion Criteria:

  • Less than 18 years of age
  • Weight greater than 120 kg.
  • Concurrent use of aminoglycosides or acyclovir
  • Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia
  • Patients currently undergoing dialysis
  • Pregnant or breast feeding
  • No plan to continue Vancomycin after admission.
  • Creatinine clearance less than 50ml/min.

Sites / Locations

  • Chrisitana Care Health System-Christiana Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study Drug 1

Study Drug 2

Arm Description

Vancomycin 15mg/kg

Vancomycin 30mg/kg

Outcomes

Primary Outcome Measures

Percentage of Participants First Achieving Therapeutic Levels at 36 Hours
The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.
Percentage of Participants First Achieving Therapeutic Levels at 12 Hours
Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL

Secondary Outcome Measures

Full Information

First Posted
July 13, 2010
Last Updated
March 12, 2014
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT01162733
Brief Title
Loading Vancomycin Doses in the Emergency Department
Acronym
Loaded
Official Title
A Randomized Prospective Study of Vancomycin Dosing in the Emergency Department: Will a Loading Dose of 30mg/kg Lead to a More Rapid Attainment of Therapeutic Levels?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.
Detailed Description
Recently, the Infectious Disease Society of America (IDSA) has released new dosing recommendations for intravenous (IV) vancomycin. These new recommendations suggest administering an initial dose of 25-30 mg/kg of vancomycin as opposed to 10-15 mg/kg which is more traditionally done. Currently in the Emergency Department (ED) some practitioners are using the new IDSA dosing recommendations for vancomycin, while other practitioners have not changed their clinical practice. There is currently little data available to suggest that implementing these new vancomycin dosing regimens in the ED will achieve therapeutic vancomycin levels more rapidly than our traditional dosing practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease
Keywords
Vancomycin, Therapeutic Levels, Infectious Disease, Recommendations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Drug 1
Arm Type
Active Comparator
Arm Description
Vancomycin 15mg/kg
Arm Title
Study Drug 2
Arm Type
Active Comparator
Arm Description
Vancomycin 30mg/kg
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
15mg/kg
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
30mg/kg
Primary Outcome Measure Information:
Title
Percentage of Participants First Achieving Therapeutic Levels at 36 Hours
Description
The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.
Time Frame
36 hours
Title
Percentage of Participants First Achieving Therapeutic Levels at 12 Hours
Description
Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Treated in Christiana Emergency Department Receiving Vancomycin for an infection or presumed infection Being admitted to Christiana Hospital Planned continued use of Vancomycin after admission. Exclusion Criteria: Less than 18 years of age Weight greater than 120 kg. Concurrent use of aminoglycosides or acyclovir Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia Patients currently undergoing dialysis Pregnant or breast feeding No plan to continue Vancomycin after admission. Creatinine clearance less than 50ml/min.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Levine, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chrisitana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

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Loading Vancomycin Doses in the Emergency Department

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