Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients
- Conditions
- Electric ImpedancePharmacokineticsCapillary Leak Syndrome
- Interventions
- Device: Bioelectrical impedance analysis to measure body composition
- Registration Number
- NCT03410771
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Admitted to ICU ward
- Treated with one of the four studied antimicrobials
- <18 years
- Pregnant
- Do Not Resuscitate code 2 or 3
- Renal replacement therapy
- ECMO
- Pacemaker/defibrillator
- Extended burns or dermatological ilness
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICU patients on meropenem Monitor antibiotic exposure (PK profile) - ICU patients on amoxicillin/clavulanic acid Monitor antibiotic exposure (PK profile) - ICU patients on amoxicillin/clavulanic acid Bioelectrical impedance analysis to measure body composition - ICU patients on meropenem Bioelectrical impedance analysis to measure body composition - ICU patients on vancomycin Monitor antibiotic exposure (PK profile) - ICU patients on piperacillin/tazobactam Bioelectrical impedance analysis to measure body composition - ICU patients on vancomycin Bioelectrical impedance analysis to measure body composition - ICU patients on piperacillin/tazobactam Monitor antibiotic exposure (PK profile) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
UZLeuven
🇧🇪Leuven, Vlaams-Brabant, Belgium