Bacterial Infections Clinical Trial
Official title:
Pharmacokinetics of Piperacillin and Tazobactam in Critically Ill Patients - Finding the Best Predictor for Piperacillin-tazobactam Clearance
Optimal understanding of piperacillin-tazobactam pharmacokinetics in critically ill patients
is lacking resulting in large variation of achieved exposure and possible inadequate therapy.
The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful
method to individualize and optimize therapy for piperacillin-tazobactam and eventually
improve outcome.
In a multi-centre, observational, open-label study the investigators aim to define PK of free
drug concentrations of both piperacillin and tazobactam in ICU patients and define a PK model
for estimation of renal function that most accurately predicts piperacillin and tazobactam
clearance.
Infections in critically ill patients are a major healthcare problem and an important source
of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics
(PK) compared to non-critically ill patients there is a substantial risk that present
standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU.
To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand
the PK of antibiotics in this vulnerable group so that dosing regimens can be optimized.
Although PK of piperacillin has been well studied in healthy volunteers, non-critically ill
patients and more recently the critically ill, there are still gaps of knowledge in the PK of
piperacillin-tazobactam in ICU patients. Especially when focusing on the influence of renal
function and on the PK of tazobactam.
Both piperacillin and tazobactam are excreted primarily by the kidneys via glomerular
filtration and tubular secretion. Elimination half life of piperacillin-tazobactam increases
with decreasing renal function. Substantial changes in renal function are common in ICU
patients. Due to these changes PK targets are often not reached. This indicates the need to
define the best predictor for piperacillin-tazobactam clearance in ICU patients in order to
improve drug dosing. The use of combined filtration markers together, cystatin C and
creatinine, can improve precision in estimating GFR (eGFR).
In a multi-centre, observational, open-label study the investigators aim to define PK of free
drug concentrations of both piperacillin and tazobactam in ICU patients and define a PK model
for estimation of renal function that most accurately predicts piperacillin and tazobactam
clearance.
Patients will receive standard care, as stated in the product characteristics or according to
local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be
retrieved through a central venous catheter or an arterial line. Full pharmacokinetic curves
will be taken for individual patients on the intermittent dosing regimen and limited sampling
will be taken for individual patients on the continuous dosing regimen. A total of 40
patients will be included.
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