Pharmacokinetics Clinical Trial
Official title:
Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients
Verified date | January 2018 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in order to guide dosing of hydrophilic antimicrobials.
Status | Completed |
Enrollment | 68 |
Est. completion date | June 1, 2016 |
Est. primary completion date | March 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZLeuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | Katholieke Universiteit Leuven |
Belgium,
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. — View Citation
Basso F, Berdin G, Virzì 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. — View Citation
Dewitte A, Carles P, Joannès-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. — View Citation
Jones SL, Tanaka A, Eastwood GM, Young H, Peck L, Bellomo R, Mårtensson J. Bioelectrical impedance vector analysis in critically ill patients: a prospective, clinician-blinded investigation. Crit Care. 2015 Aug 12;19:290. doi: 10.1186/s13054-015-1009-3. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Samoni S, Vigo V, Reséndiz 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | 1 day |
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