Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

C

CAMC Health System

Status

Unknown

Conditions

Infection
Obesity
Sepsis

Treatments

Drug: IV vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT02764359
15-120

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

IV Vancomycin loading dose- higher
Experimental group
Description:
IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg
Treatment:
Drug: IV vancomycin
IV Vancomycin loading dose- lower
Experimental group
Description:
IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg
Treatment:
Drug: IV vancomycin

Trial contacts and locations

1

Loading...

Central trial contact

Adam Crawford, DO; William Payne, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems