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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Capillary Leak Syndrome; Electric Impedance; Pharmacokinetics

Treatments: Device: Bioelectrical impedance analysis to measure body composition; Drug: Monitor antibiotic exposure (PK profile)

Study type: Observational

Funder types: Other

Identifiers

NCT03410771

mp05488

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

68 participants in 4 patient groups

ICU patients on amoxicillin/clavulanic acid

Treatment:

Device: Bioelectrical impedance analysis to measure body composition

Drug: Monitor antibiotic exposure (PK profile)

ICU patients on piperacillin/tazobactam

Treatment:

Device: Bioelectrical impedance analysis to measure body composition

Drug: Monitor antibiotic exposure (PK profile)

ICU patients on meropenem

Treatment:

Device: Bioelectrical impedance analysis to measure body composition

Drug: Monitor antibiotic exposure (PK profile)

ICU patients on vancomycin

Treatment:

Device: Bioelectrical impedance analysis to measure body composition

Drug: Monitor antibiotic exposure (PK profile)