Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial. This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.
CAMC Health Systems
Charleston, West Virginia, United States
RECRUITINGTime to attain therapeutic vancomycin concentrations
Time frame: < 7 days
Reported adverse events
Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso. Nephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements.
Time frame: 48 hours post initial vancomycin dose
Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose
Time frame: 12 hours
Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose
Time frame: 12 hours
Intensive care unit length of stay
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
In-hospital mortality
Time frame: 30 days
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