Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136796
• Other study ID #: AZVCR 9307_4
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results).

Exclusion Criteria:

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Meropenem
Patients will receive intravenous antibiotics eighter empirically or based on a culture.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Králové	Trebeš

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Arora N, Islam S, Wafa K, Zhou J, Toguri JT, Cerny V, Lehmann C. Evaluation of iris functional capillary density in experimental local and systemic inflammation. J Microsc. 2017 Apr;266(1):55-59. doi: 10.1111/jmi.12518. Epub 2017 Jan 19. — View Citation

Astapenko D, Jor O, Lehmann C, Cerny V. In situ assessment of the renal microcirculation in mechanically ventilated rats using sidestream dark-field imaging. J Microsc. 2015 Feb;257(2):161-5. doi: 10.1111/jmi.12198. Epub 2014 Dec 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months