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Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03410771
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Matthias Gijsen, Universitaire Ziekenhuizen Leuven

Brief Summary:
Bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in order to guide dosing of hydrophilic antimicrobials.

Condition or disease Intervention/treatment
Electric Impedance Pharmacokinetics Capillary Leak Syndrome Drug: Monitor antibiotic exposure (PK profile) Device: Bioelectrical impedance analysis to measure body composition

Detailed Description:

Abstract Background: Recent data suggest that antimicrobial pharmacokinetics (PK) like volume of distribution (Vd) or drug clearance (CL) is extremely altered in critically ill patients with sepsis or septic shock due to pathophysiological alterations (e.g. influence on fluid status). Bioelectrical impedance analysis (BIA) was recently introduced as a simple, non-invasive, bedside technique to assess hydration status. The primary aim of the present study was to explore the correlation between BIA parameters and Vd of hydrophilic antimicrobial agents in critically ill patients. Furthermore, the relationship between BIA measurements and clinical observations was evaluated.

Methods: We performed a validation study in healthy volunteers in September 2015 that confirmed the reproducibility of BIA. Subsequently, a prospective observational study was carried out in eligible patients treat-ed with amoxicillin/clavulanic acid, meropenem, piperacillin/tazobactam or vancomycin, admitted at the in-tensive care unit (ICU) of the University Hospitals Leuven from October 2015 to March 2016. BIA measurement was performed on the same day as the collection of blood samples to calculate PK parameters of the administered antibiotic.


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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
ICU patients on amoxicillin/clavulanic acid Drug: Monitor antibiotic exposure (PK profile)
several plasma samples to measure drug exposure

Device: Bioelectrical impedance analysis to measure body composition
non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.

ICU patients on piperacillin/tazobactam Drug: Monitor antibiotic exposure (PK profile)
several plasma samples to measure drug exposure

Device: Bioelectrical impedance analysis to measure body composition
non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.

ICU patients on meropenem Drug: Monitor antibiotic exposure (PK profile)
several plasma samples to measure drug exposure

Device: Bioelectrical impedance analysis to measure body composition
non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.

ICU patients on vancomycin Drug: Monitor antibiotic exposure (PK profile)
several plasma samples to measure drug exposure

Device: Bioelectrical impedance analysis to measure body composition
non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.




Primary Outcome Measures :
  1. Correlation between BIA parameters and Vd of hydrophilic antimicrobial agents [ Time Frame: 6-12 hours (= dosing interval) depending on the antimicrobial studied ]
    Extracellular water (ECW), intracellular water, total body water (TBW), all expressed in liter, and ECW expressed as % of TBW will be correlated with Vd (L/kg) of vancomycin, meropenem, amoxicillin/clavulanic acid and piperacillin/tazobactam


Secondary Outcome Measures :
  1. Correlation between BIA assessed hydration status and clinical observations [ Time Frame: 1 day ]
    Hydration status measured by BIA (dehydrated, normohydrated, hyperhydrated) will be correlated with SOFA score and cumulative fluid balance (L)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to our intensive care unit
Criteria

Inclusion Criteria:

  • Admitted to ICU ward
  • Treated with one of the four studied antimicrobials

Exclusion Criteria:

  • <18 years
  • Pregnant
  • Do Not Resuscitate code 2 or 3
  • Renal replacement therapy
  • ECMO
  • Pacemaker/defibrillator
  • Extended burns or dermatological ilness

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): NCT03410771


Locations
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Belgium
UZLeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Study Director: Isabel Spriet, PharmD PhD Universitaire Ziekenhuizen Leuven

Publications:

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Responsible Party: Matthias Gijsen, PharmD PhD researcher - Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03410771     History of Changes
Other Study ID Numbers: mp05488
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthias Gijsen, Universitaire Ziekenhuizen Leuven:
Distribution Volume
Antibiotics

Additional relevant MeSH terms:
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Critical Illness
Capillary Leak Syndrome
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents