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Loading Vancomycin Doses in the Emergency Department (Loaded)

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: NCT01162733
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : March 13, 2014
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infectious Disease Drug: Vancomycin Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study Drug 1
Vancomycin 15mg/kg
 Drug: Vancomycin
15mg/kg
Active Comparator: Study Drug 2
Vancomycin 30mg/kg
 Drug: Vancomycin
30mg/kg


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants First Achieving Therapeutic Levels at 36 Hours [ Time Frame: 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.

  2. Percentage of Participants First Achieving Therapeutic Levels at 12 Hours [ Time Frame: 12 hours ]
    Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT01162733


Locations
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United States, Delaware
Chrisitana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
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Principal Investigator: Brian Levine, MD Christiana Care Health Services
More Information
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Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01162733    
Other Study ID Numbers: 30029
First Posted: July 15, 2010    Key Record Dates
Results First Posted: March 13, 2014
Last Update Posted: March 13, 2014
Last Verified: March 2014
Keywords provided by Christiana Care Health Services:
Vancomycin
Therapeutic Levels
Infectious Disease
Recommendations
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Emergencies
Disease Attributes
 Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents