Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

NCT03136796 | Completed FDA Drug

• 1 other identifier: AZVCR 9307_4
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Perfused Boundary Region

  6 months

Interventions

Meropenem DRUG

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

Also known as: Piperacillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted to ICU due to sepsis or polytrauma in need for intravenous antibiotic therapy.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

Location

Related Publications (2)

• 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.

  PMID: 25545609 BACKGROUND

• 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.

  PMID: 28102536 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Meropenem; Piperacillin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vladimir Cerny, MD, PhD, FCCM

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: May 2, 2017
• Study Start: May 2, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)