Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

NCT ID: NCT03136796

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2018-09-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Meropenem

Patients will receive intravenous antibiotics eighter empirically or based on a culture.

Intervention Type: DRUG

Other Intervention Names

Piperacillin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Hradec Kralove

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Cerny

Vladimir Cerny, MD, PhD, FCCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Hradec Kralove

Hradec Králové, Třebeš, Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 25545609 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28102536 (View on PubMed)

Other Identifiers

AZVCR 9307_4

Identifier Type: -

Identifier Source: org_study_id