Loading Vancomycin Doses in the Emergency Department (Loaded)

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?

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease
• Intervention / Treatment: Drug: Vancomycin; Drug: Vancomycin

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Chrisitana Care Health System-Christiana Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Study Drug 1; Vancomycin 15mg/kg	Drug: Vancomycin; 15mg/kg; Drug: Vancomycin; 30mg/kg
ACTIVE_COMPARATOR: Study Drug 2; Vancomycin 30mg/kg	Drug: Vancomycin; 15mg/kg; Drug: Vancomycin; 30mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 hours
Percentage of Participants First Achieving Therapeutic Levels at 12 Hours	Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL	12 hours

Collaborators and Investigators

• Sponsor: Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (ESTIMATE): July 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Vancomycin; Infectious Disease; Recommendations; Therapeutic Levels
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 30029