NCT03410771

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

January 8, 2018

Last Update Submit

January 26, 2018

Conditions

Electric ImpedancePharmacokineticsCapillary Leak Syndrome

Keywords

Distribution VolumeAntibiotics

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

  • Correlation between BIA assessed hydration status and clinical observations

    1 day

Study Arms (4)

ICU patients on amoxicillin/clavulanic acid

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

ICU patients on piperacillin/tazobactam

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

ICU patients on meropenem

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

ICU patients on vancomycin

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

Interventions

Monitor antibiotic exposure (PK profile)DRUG

several plasma samples to measure drug exposure

ICU patients on amoxicillin/clavulanic acidICU patients on meropenemICU patients on piperacillin/tazobactamICU patients on vancomycin
Bioelectrical impedance analysis to measure body compositionDEVICE

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

ICU patients on amoxicillin/clavulanic acidICU patients on meropenemICU patients on piperacillin/tazobactamICU patients on vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to our intensive care unit

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (8)

  • 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.

    PMID: 26260579BACKGROUND

  • 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.

    PMID: 15973917BACKGROUND

  • 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.

    PMID: 25432557BACKGROUND

  • 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.

    PMID: 26018457BACKGROUND

  • 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.

    PMID: 28380407BACKGROUND

  • 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.

    PMID: 27060079BACKGROUND

  • 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.

    PMID: 24768475BACKGROUND

  • 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.

    PMID: 24496190BACKGROUND

MeSH Terms

Conditions

Capillary Leak Syndrome

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Isabel Spriet, PharmD PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD PhD researcher - Principal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 25, 2018

Study Start

October 1, 2015

Primary Completion

March 31, 2016

Study Completion

June 1, 2016

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

BE(1)