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Trial record 69 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

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ClinicalTrials.gov Identifier: NCT03136796
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Vladimir Cerny, University Hospital Hradec Kralove

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.

Condition or disease Intervention/treatment
Critical Illness Drug: Meropenem

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Meropenem


Intervention Details:
  • Drug: Meropenem
    Patients will receive intravenous antibiotics eighter empirically or based on a culture.
    Other Name: Piperacillin


Primary Outcome Measures :
  1. Plasmatic concentrations of antibiotics [ Time Frame: 6 months ]
    Concentration of antibiotics will be assessed in plasma after their administration in mmol/l to calculate their pharmacokinetic and pharmacodynamic profile.


Secondary Outcome Measures :
  1. Perfused Boundary Region [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to ICU due to sepsis or polytrauma in need for intravenous antibiotic therapy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136796


Locations
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Czechia
University Hospital Hradec Kralove
Hradec Králové, Třebeš, Czechia, 50005
Sponsors and Collaborators
University Hospital Hradec Kralove

Publications:
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Responsible Party: Vladimir Cerny, Vladimir Cerny, MD, PhD, FCCM, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT03136796     History of Changes
Other Study ID Numbers: AZVCR 9307_4
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents