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Research type
Research Study
Full title
Pharmacokinetics of Gentamicin in Critical Illness
IRAS ID
148223
Contact name
Catherine McKenzie
Contact email
Sponsor organisation
Guy's and St. Thomas' NHS Foundation Trust
Eudract number
2015-004579-62
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The optimum choice, dose and timely administration of antibiotic treatment is imperative in the management of infection in critical illness. In order to study the effectiveness of antibiotics, which is what the drug does to the body (pharmacodynamics), we must first seek to understand how the body in critical illness absorbs, distributes, metabolises and eliminates the drug (Pharmacokinetics-PK).This will allow us to know if we are using the correct doses in special population groups such as in critical illness.
It is well documented that the Pk of antibiotics vary significantly in the critically ill population. This variability stems from the complex physiological changes that occur in critical illness. Changes to volume of distribution and clearance for example will affect how much drug concentration there is at the infection site which will determine its effectiveness.
The proposed study seeks to describe the Pk of gentamicin in the general critical care population at Guy's & St.Thomas' Foundation Trust (GSTFT). We chose Gentamicin as it is an effective and important antibiotic used for sepsis at GSTFT and we will like to continue to preserve its effectiveness through better understanding of its PK in critical illness and optimise its dosing as appropriate.
We seek to define the range of Pk parameters of gentamicin including volume of distribution (Vd), Elimination rate constant (k), Elimination half life (t1/2) and Clearance (Cl). This will be done by collecting 4 to 6 serum samples over a gentamicin dosing interval.
These levels will then be put into a mathematical population-based PK model using a computer programming system called PMetrics to allow us to estimate the pharmacokinetics of gentamicin in our special population of critically ill patients.REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1118
Date of REC Opinion
28 Oct 2016
REC opinion
Further Information Favourable Opinion