Trial document




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  DRKS00005694

Trial Description

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Title

Influence of ECMO on concentration-time courses of certain antibiotics in patients with acute lung failure

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Trial Acronym

ECMO-PHANT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Extracorporeal gas exchange (ECMO, i.e. extracorporeal membrane oxygenation) may be necessary in case of severe pulmonary failure. Artificial surfaces, as used in these devices, may absorb drugs, for example antibiotics. Such an absorption would cause a diminished effect against microbes. Up to now there are insufficient data to guide antibiotic dosing for patients on ECMO.
Aim of our study is to analyse the effect of ECMO on the concentration of two different antibiotics. For this purpose the level of these drugs will be analysed before and after start of ECMO.

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Brief Summary in Scientific Language

Extracorporeal membrane oxygenation (ECMO) or extracorporeal CO2 removal (ECCO2-R) may influence pharmacokinetics of antibiotics due to adsorption and changing volume of distribution. Data to guide dosing of antibiotics in patients on ECMO are scarce.
Aim of our study is to analyse the change in pharmacokinetics of Cefotaxime and Meropenem in patients with acute respiratory failure, who need ECMO or ECCO2-R. We compare the time course of the serum concentration of a dose of Cefotaxime or Meropenem before starting ECMO and afterwards by analysing the serum levels before, and at different timepoints after application of the substance.

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Organizational Data

  •   DRKS00005694
  •   2014/02/04
  •   [---]*
  •   yes
  •   Approved
  •   BB 152/13a, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

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Health Condition or Problem studied

  •   J80 -  Adult respiratory distress syndrome
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Interventions/Observational Groups

  •   Patients with ARDS and indication for ECMO and indication for antibiotic therapy with Cefotaxime or Meropenem. We analyse the time course of its serum concentration before the start of ECMO and during EMCO therapy in the same patient.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

concentration - time - course of Cefotaxime and Meropenem without and with ECMO (extracorporeal membrane oxygenation)

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/03/01
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with
1. ARDS with indication for ECMO or ECCO2-R (i.e. p/F < 100 with FiO2 > 79 and individually optimised PEEP and/or pH < 7,30)

and

2. indication for Cefotaxime or Meropenem

and

3. informed consent

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Exclusion Criteria

- emergency ECMO < 6 h after ICU admission
- start of renal replacement therapy simultanously or less than 6 hours after start of ECMO
- contraindication for cefotaxime or meropenem
- v/a ECMO
- hemodynamic instability with unsteady demand of norepinephrine (> 20 % difference in norepinephrine dose during the last hours)

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Addresses

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    • Institut für Klinische PharmakologieUniversität Greifswald
    • Felix-Hausdorff-Str. 3
    • 17487  Greifswald
    • Germany
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    •   +49-(03834) 865637
    •   +49-(03834) 865631
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    •   [---]*
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    • Universitätsmedizin GreifswaldKlinik für Innere Medizin BInternistische Intensivstation
    • Ms.  Dr  Sigrun  Friesecke 
    • Ferdinand Sauerbruch STr. 1
    • 17475  Greifswald
    • Germany
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    • Universitätsmedizin GreifswaldKlinik für Innere Medizin B
    • Ms.  Dr.  Sigrun  Friesecke 
    • Ferdinand Sauerbruch Str. 1
    • 17475  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Klinische PharmakologieUniversität Greifswald
    • Felix-Hausdorff-Str. 3
    • 17487  Greifswald
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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