An observational study in Critical Illness, sponsored by University Hospital Hradec Kralove. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by University Hospital Hradec Kralove · Observational
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 20 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital Hradec Kralove is the lead sponsor of 46 studies on the registry; 13 are open to participants now.
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Adult patients admitted to ICU due to sepsis or polytrauma in need for intravenous antibiotic therapy.
Exclusion Criteria:
Patients will receive intravenous antibiotics eighter empirically or based on a culture.
Also known as: Piperacillin
Plasmatic concentrations of antibiotics
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
Perfused Boundary Region
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.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University Hospital Hradec Kralove