Infection, Obesity, Sepsis
Conditions
Brief summary
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.
Interventions
DRUGIV vancomycin
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.
Sponsors
CAMC Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department * Weight \>100kg * Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital
Exclusion criteria
* Any patient \<18 years of age * Patients on dialysis or with unstable renal function (a change of \>0.5 mg/dL in SCr concentration in patients with a SCr of \<2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to attain therapeutic vancomycin concentrations | < 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose | 12 hours | — |
| Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose | 12 hours | — |
| Reported adverse events | 48 hours post initial vancomycin dose | 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. |
| Hospital length of stay | 30 days | — |
| In-hospital mortality | 30 days | — |
| Intensive care unit length of stay | 30 days | — |
Countries
United States
Contacts
Primary ContactWilliam Payne, MD
Backup ContactAdam Crawford, DO
Outcome results
None listed