Septic Shock Clinical Trial
Official title:
Meropenem and Ciprofloxacin Dosing in the Critically Ill Patient With Septic Shock - a Single Center Pharmacokinetic Study
Patients with septic shock may have altered volume of distribution and metabolism of antibiotics which are crucial medications for treating infections. The aim of the study is to investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used antibiotics, in patients with septic shock. The hypothesis is that standard dosing may produce insufficient levels of antibiotics in patients with septic shock.
Sepsis may induce changes in renal function, increased capillary leakage and frequently
blood-flow stasis in the peripheral tissues leading to an increase in the water space and
diffusion distances. Significant changes have been observed in the distribution volume of
certain antibiotics in patients with sepsis. The increased volume of distribution of
water-soluble drugs is caused by a capillary leak syndrome that results in a net movement of
fluid from the intravascular compartment into tissues. This capillary leak syndrome has been
well described in patients with sepsis and may result in low trough serum concentrations.
This, in turn, may result in a slow antibiotic penetration of tissues and a low tissue
antibiotic concentration. Treatment failure may result if antibiotic choice or doses are
incorrect and there is a lack of information which describes how to alter drug dosing in
response to this increased volume of distribution in sepsis. Previous research has shown
that some intensive care unit (ICU) patients have larger than normal between subject
variability in drug clearance and volumes that can be attributed to supranormal renal
clearances.
Aims of the present study:
1. To evaluate present meropenem and ciprofloxacin dosing and achieved plasma
concentrations in relation to bacterial susceptibility.
2. To evaluate how to accurately dose meropenem and ciprofloxacin in patients with sepsis
The overall hypothesis for this project is that some patients admitted to ICU with
severe sepsis are undertreated with meropenem and ciprofloxacin using the dosing based
on that recommended by the Product Information
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Observational Model: Cohort, Time Perspective: Prospective
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|---|---|---|---|
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