Loading Vancomycin Doses in the Emergency Department

Infectious Disease Clinical Trial

— 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162733
• Other study ID #: 30029
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: March 12, 2014
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2014
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• Vancomycin
15mg/kg
• Vancomycin
30mg/kg

Locations

Country	Name	City	State
United States	Chrisitana Care Health System-Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No