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Electric ImpedanceNCT03410771

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

An observational study of Electric Impedance and Pharmacokinetics, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Monitor antibiotic exposure (PK profile) and Bioelectrical impedance analysis to measure body composition
Type of treatment
Medical device
How many people
68 participants
Where
1 siteBelgium
Study dates
1 Oct 2015to 1 Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to our intensive care unit

Who may be able to join

  • Admitted to ICU ward
  • Treated with one of the four studied antimicrobials

Who cannot join

  • <18 years
  • Pregnant
  • Do Not Resuscitate code 2 or 3
  • Renal replacement therapy
  • ECMO
  • Pacemaker/defibrillator
  • Extended burns or dermatological ilness

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZLeuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

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

Read the 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.

Being tested
Monitor antibiotic exposure (PK profile), Bioelectrical impedance analysis to measure body composition
Keywords
Distribution Volume, Antibiotics
Medical subject headings
Capillary Leak Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitor antibiotic exposure (PK profile)Drug

    several plasma samples to measure drug exposure

  • Bioelectrical impedance analysis to measure body compositionDevice

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

Study groups in NCT03410771
Study groupRoleWhat they receive
ICU patients on amoxicillin/clavulanic acidNot described
Receives: Drug: Monitor antibiotic exposure (PK profile); Device: Bioelectrical impedance analysis to measure body composition
ICU patients on piperacillin/tazobactamNot described
Receives: Drug: Monitor antibiotic exposure (PK profile); Device: Bioelectrical impedance analysis to measure body composition
ICU patients on meropenemNot described
Receives: Drug: Monitor antibiotic exposure (PK profile); Device: Bioelectrical impedance analysis to measure body composition
ICU patients on vancomycinNot described
Receives: Drug: Monitor antibiotic exposure (PK profile); Device: Bioelectrical impedance analysis to measure body composition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between BIA parameters and Vd of hydrophilic antimicrobial agents

    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

    Measured: 6-12 hours (= dosing interval) depending on the antimicrobial studied

Secondary outcomes (1)

  1. Correlation between BIA assessed hydration status and clinical observations

    Hydration status measured by BIA (dehydrated, normohydrated, hyperhydrated) will be correlated with SOFA score and cumulative fluid balance (L)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2018
  2. Study start1 Oct 2015
  3. Primary completion31 Mar 2016
  4. Study completion1 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03410771
Sponsor's protocol ID
mp05488
Status last verified
Jan 2018
First submitted
8 Jan 2018
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: To be determined

Publications

  • Jones SL, Tanaka A, Eastwood GM, Young H, Peck L, Bellomo R, Martensson J. Bioelectrical impedance vector analysis in critically ill patients: a prospective, clinician-blinded investigation. Crit Care. 2015 Aug 12;19(1):290. doi: 10.1186/s13054-015-1009-3.

    PubMed 26260579

  • Balik M, Sedivy J, Waldauf P, Kolar M, Smejkalova V, Pachl J. Can bioimpedance determine the volume of distribution of antibiotics in sepsis? Anaesth Intensive Care. 2005 Jun;33(3):345-50. doi: 10.1177/0310057X0503300310.

    PubMed 15973917

  • Malbrain ML, Huygh J, Dabrowski W, De Waele JJ, Staelens A, Wauters J. The use of bio-electrical impedance analysis (BIA) to guide fluid management, resuscitation and deresuscitation in critically ill patients: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):381-91. doi: 10.5603/AIT.2014.0061.

    PubMed 25432557

  • Dewitte A, Carles P, Joannes-Boyau O, Fleureau C, Roze H, Combe C, Ouattara A. Bioelectrical impedance spectroscopy to estimate fluid balance in critically ill patients. J Clin Monit Comput. 2016 Apr;30(2):227-33. doi: 10.1007/s10877-015-9706-7. Epub 2015 May 29.

    PubMed 26018457

  • Lee YH, Lee JD, Kang DR, Hong J, Lee JM. Bioelectrical impedance analysis values as markers to predict severity in critically ill patients. J Crit Care. 2017 Aug;40:103-107. doi: 10.1016/j.jcrc.2017.03.013. Epub 2017 Mar 22.

    PubMed 28380407

  • Samoni S, Vigo V, Resendiz LI, Villa G, De Rosa S, Nalesso F, Ferrari F, Meola M, Brendolan A, Malacarne P, Forfori F, Bonato R, Donadio C, Ronco C. Impact of hyperhydration on the mortality risk in critically ill patients admitted in intensive care units: comparison between bioelectrical impedance vector analysis and cumulative fluid balance recording. Crit Care. 2016 Apr 8;20:95. doi: 10.1186/s13054-016-1269-6.

    PubMed 27060079

  • Roberts JA, Abdul-Aziz MH, Lipman J, Mouton JW, Vinks AA, Felton TW, Hope WW, Farkas A, Neely MN, Schentag JJ, Drusano G, Frey OR, Theuretzbacher U, Kuti JL; International Society of Anti-Infective Pharmacology and the Pharmacokinetics and Pharmacodynamics Study Group of the European Society of Clinical Microbiology and Infectious Diseases. Individualised antibiotic dosing for patients who are critically ill: challenges and potential solutions. Lancet Infect Dis. 2014 Jun;14(6):498-509. doi: 10.1016/S1473-3099(14)70036-2. Epub 2014 Apr 24.

    PubMed 24768475

  • Basso F, Berdin G, Virzi GM, Mason G, Piccinni P, Day S, Cruz DN, Wjewodzka M, Giuliani A, Brendolan A, Ronco C. Fluid management in the intensive care unit: bioelectrical impedance vector analysis as a tool to assess hydration status and optimal fluid balance in critically ill patients. Blood Purif. 2013;36(3-4):192-9. doi: 10.1159/000356366. Epub 2013 Dec 20.

    PubMed 24496190

Questions about this trial

What is this clinical trial studying?

An observational study of Electric Impedance and Pharmacokinetics, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between BIA parameters and Vd of hydrophilic antimicrobial agents (time frame: 6-12 hours (= dosing interval) depending on the antimicrobial studied). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03410771, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

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