Vancomycin dosing in obesity

• Research type

  Research Study

• Full title

  Population pharmacokinetics of intravenous vancomycin and development of vancomycin dosage guidelines for adult patients with obesity.

• IRAS ID

  181420

• Contact name

  Alison Thomson

• Contact email

  alison.h.thomson@strath.ac.uk

• Sponsor organisation

  University of Strathclyde

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  Vancomycin is an antibiotic that is used to treat potentially life-threatening infections. Initial doses are based on the patient’s sex, height, weight, age and kidney function. Doses are then adjusted according to the level of vancomycin in the patient’s blood. If the level is too low, the patient is at risk of treatment failure. If the level is too high, the patient may experience toxic effects, such as kidney damage.

  It is not clear if current vancomycin dosage guidelines are appropriate for adult patients who are obese (BMI ≥30 Kg/m2). This study will investigate how vancomycin is handled in obese patients and, if necessary, devise new dosage guidelines.
  Clinical details, vancomycin dose and concentration data will be identified from electronic records of adult patients within NHS Greater Glasgow and Clyde who were treated with intravenous vancomycin and whose body mass index is 30 kg/m2 or higher. Data will be extracted from routine electronic and hard copy therapeutic drug monitoring files, which are created when pharmacists advise doctors on vancomycin dosage regimens for individual patients, and from datasets generated for previous audits or service reviews. Where required, additional data will be extracted from laboratory files. Data will be analysed using a population pharmacokinetic modelling package (NONMEM). The analysis will aim to identify the clinical factors that influence how vancomycin is handled by the body with a particular focus on the impact of patient weight. An electronic dataset of simulated patients will then be created and the results of the analysis will be used to examine the performance of current dosage guidelines. If necessary, new dosage guidelines, targeted at obese patients, will be designed then evaluated using the simulated data. The results of the study will be used to inform updates to local and national guidelines for vancomycin use.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  15/ES/0148

• Date of REC Opinion

  9 Sep 2015

• REC opinion

  Favourable Opinion