Medical Device Derived Pharmacokinetic Parameters for Vancomycin
Research type
Research Study
Full title
An investigation into how medical device obtained variables influence the pharmacokinetic profile of vancomycin: a paediatric and adult critical care feasibility assessment at a London tertiary-care hospital
IRAS ID
324055
Contact name
Rosie Jacobs
Contact email
Sponsor organisation
St George's, University of London
Clinicaltrials.gov Identifier
NIHR302720, HEE-NIHR Integrated Clinical and Practitioner Academic Programme Contract Reference; To be added once published, ClinicalTrials.gov reference
Duration of Study in the UK
1 years, 2 months, days
Research summary
Summary of Research:
Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment).Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate.
We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George’s Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient’s treatment.
In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.
Summary of Findings:
Background It is important to be sure that the amount of an antibiotic given (a medicine to treat infections) is correct. Computer software is often used to help doctors and other health professionals with this. Getting the amount of antibiotic correct helps treat the infection and prevent bugs becoming resistant to antibiotic effects. For the computer software to work properly, we need to precisely understand the times and amounts of antibiotics that are being given.Objectives
We set out to understand how best to record information about antibiotics being given to treat infection. We set out to compare the electronic patient record (that doctors and nurses enter times into) and devices used to give the antibiotics (that automatically record the time).Methods
As part of a study, adults and children treated with vancomycin (an antibiotic) for an infection had some blood taken to measure the amount of vancomycin in the blood. We took information from the electronic patient record and the devices used to give the vancomycin. A computer model calculated the most accurate recording method. The computer also calculated if the amounts of vancomycin given met the target amount needed to prevent infection resistance.Results
In children, the most accurate vancomycin recording method was the electronic patient record. But in adults, the most accurate recording method was from the devices used to give vancomycin injections. Computer model calculations of the target to supress infection resistance were different depending on the recording method used. Recording method accuracy was therefore shown to be important.Conclusions
The way vancomycin amounts and timings are recorded at the hospital where the study took place, affected the accuracy of computer model calculations. This affected how targets to prevent infection resistance occurring were calculated. This is important as if the calculations are not correct, people may experience unnecessary side effects or be at increased risk of having a resistant infection from their treatment. Recording problems were caused by human errors, which were linked to how vancomycin injections were given and where people had treatment. In the future, people using computer models to give better amounts of antibiotics, should talk about what recording method they used and how they prevented errors happening.REC name
Wales REC 5
REC reference
23/WA/0125
Date of REC Opinion
27 Apr 2023
REC opinion
Favourable Opinion