NCT03136796

Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DRUG	Meropenem	Patients will receive intravenous antibiotics eighter empirically or based on a culture.

Timeline

• Start date: 2017-05-02
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2017-05-02
• Last updated: 2018-10-24

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated drug study