Renal Failure Chronic Requiring Hemodialysis Clinical Trial
Official title:
Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients.
Aminoglycosides are widely used for the treatment of Gram-negative bacilli and Staphylococcus
aureus infections because of their effectiveness and low cost. Nevertheless, many aspects of
their optimal use in hemodialysis patients remain unsolved and little is known about their
pharmacokinetics in this context. The current practice for prescribing aminoglycosides to
these particular patients consists in giving after each hemodialysis session about half the
dose usually given to patients with normal renal function.
However, theoretical considerations and emerging clinical data suggest that this may not be
the most beneficial dosing regimen as efficient peak concentrations are often not attained
and the occurrence of ototoxicity and nephrotoxicity is still frequent.
Recent evidence about the pharmacokinetics and pharmacodynamics of aminoglycosides strongly
supports administration of aminoglycosides before, rather than after, hemodialysis.
Therapeutic drug monitoring using pharmacokinetic modeling is currently used in
non-hemodialysis patients. However, the PK tools employed are not suitable to dialysis
patients.
For aminoglycosides, the ratio of peak to Minimal Inhibitory Concentration (MIC) has been
shown to be the parameter that best correlates with clinical efficacy, whilst prolonged
exposure to high concentrations have been related to either nephrotoxicity or ototoxicity.
Additionally, aminoglycosides are mostly excreted as unchanged drugs in urine and their
clearance is directly proportional to the glomerular filtration rate. The elimination
half-life of aminoglycosides is approximately 1.5-3 hours in adults with normal renal
function, but is greatly prolonged up to 36-70 hours in patients with end-stage renal
failure. In a standard patient, aminoglycosides are administered as a single dose, over a
short time interval, to obtain an elevated blood peak concentration (the effective level).
The next injection is not administered before 24 hours, to allow the patient to wash out the
aminoside and to minimize the residual blood concentration (the toxic level). The aim here is
to maximize the peak concentration during a fair amount of time (by repeating the peaks) and
to minimize the overall drug exposure, responsible for the toxicity.
For the renal impaired patient, our hypothesis is that the hemodialyzer can be regarded as a
kidney. Thus, the administration of the aminoside at the beginning of the hemodialysis could
lead to profiles of elimination comparable to those observed in normorenal patients.
The research aims at performing a population pharmacokinetic (POPPK) study of gentamicin when
given to hemodialysis patients.
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