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

January 26, 2018 updated by: Matthias Gijsen, Universitaire Ziekenhuizen KU Leuven
Bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in order to guide dosing of hydrophilic antimicrobials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to our intensive care unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-12 hours (= dosing interval) depending on the antimicrobial studied

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven

Investigators

  • Study Director: Isabel Spriet, PharmD PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mp05488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

To be determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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