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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients

NCT05991778

Respiratory Distress Syndrome, Acute Respiratory Insufficiency Lung Ventilator +4 more

COMPLETED

Bioimpedance Analysis in Septic Intensive Care Unit (ICU) Patients

NCT01379404

Sepsis

COMPLETED

Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods

NCT01766531

Body Composition

COMPLETED PHASE4

Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS

NCT01272882

Acute Lung Injury (ALI) ARDS

COMPLETED NA

Muscle and Subcutaneous Tissue Variation by Ultrasound and Impedance Linked to Fluid Balance in ICU Patients

NCT06697470

Weakness Acquired in the ICU Muscle Wasting Edema +3 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Electric Impedance Pharmacokinetics Capillary Leak Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU patients on amoxicillin/clavulanic acid

Monitor antibiotic exposure (PK profile)

Intervention Type DRUG

several plasma samples to measure drug exposure

Bioelectrical impedance analysis to measure body composition

Intervention Type DEVICE

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

ICU patients on piperacillin/tazobactam

Monitor antibiotic exposure (PK profile)

Intervention Type DRUG

several plasma samples to measure drug exposure

Bioelectrical impedance analysis to measure body composition

Intervention Type DEVICE

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

ICU patients on meropenem

Monitor antibiotic exposure (PK profile)

Intervention Type DRUG

several plasma samples to measure drug exposure

Bioelectrical impedance analysis to measure body composition

Intervention Type DEVICE

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

ICU patients on vancomycin

Monitor antibiotic exposure (PK profile)

Intervention Type DRUG

several plasma samples to measure drug exposure

Bioelectrical impedance analysis to measure body composition

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Monitor antibiotic exposure (PK profile)

several plasma samples to measure drug exposure

Intervention Type DRUG

Bioelectrical impedance analysis to measure body composition

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No