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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03410771

Enrollment

Registered

2018-01-25

Start date

2015-10-01

Completion date

2016-06-01

Last updated

2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capillary Leak Syndrome, Electric Impedance, Pharmacokinetics

Keywords

Distribution Volume, Antibiotics

Brief summary

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

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.

Interventions

DRUGMonitor antibiotic exposure (PK profile)

several plasma samples to measure drug exposure

DEVICEBioelectrical impedance analysis to measure body composition

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between BIA parameters and Vd of hydrophilic antimicrobial agents	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

Measure	Time frame	Description
Correlation between BIA assessed hydration status and clinical observations	1 day	Hydration status measured by BIA (dehydrated, normohydrated, hyperhydrated) will be correlated with SOFA score and cumulative fluid balance (L)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026