Clinical trial NCT03410771: Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients
Official title: Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electric Impedance
Pharmacokinetics
Capillary Leak Syndrome
Keywords: Distribution Volume
Antibiotics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2018-01-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to our intensive care unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between BIA parameters and Vd of hydrophilic antimicrobial agents
timeFrame: 6-12 hours (= dosing interval) depending on the antimicrobial studied
Secondary outcomes:
measure: Correlation between BIA assessed hydration status and clinical observations
timeFrame: 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Isabel Spriet, PharmD PhD
role: STUDY_DIRECTOR
References:
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