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Completed

NCT Number: NCT03410771

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitor antibiotic exposure (PK profile)

Drug

several plasma samples to measure drug exposure

Bioelectrical impedance analysis to measure body composition

Device

non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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