University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005, Czechia
NCT Number: NCT03136796
GCX damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam antibiotics in critically ill Hypothesis to be tested: GCX damage impairs pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill patients. There is correlation between GCX damage and insufficient beta lactam levels in patients with commonly used dosing. The aim of the study: Evaluation of relationship between GCX damage and pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. Type of the study: Observational. Subjects: Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). Sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha error = 0,05) will lead to power study = 0,89. Intervention: none. Data to be recorded and analyzed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, a presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging will be recorded three times during antibiotic treatment at the time points for blood samples required for pharmacodynamics and pharmacokinetic analysis, microcirculatory data and Perfused Boundary Region.
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Notify Me18 year and older
All sexes
Observational
Hradec Králové, Třebeš, 50005, Czechia
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive intravenous antibiotics eighter empirically or based on a culture.
Other names: Piperacillin
Time frame: 6 months
Concentration of antibiotics will be assessed in plasma after their administration in mmol/l to calculate their pharmacokinetic and pharmacodynamic profile.
Time frame: 6 months
PBR is a parameter obtained automatically by specialized software after examination of the sublingual microcirculation by handheld microscope that describes the amount of glycocalyx destruction.
University Hospital Hradec Kralove
Other
Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection
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