Trial document





This trial has been registered retrospectively.
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  DRKS00010765

Trial Description

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Title

Pharmacokinetics of selected antiinfectives during extracorporeal membrane oxygenation (ECMO)

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Trial Acronym

PhA-ECMO

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URL of the Trial

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Brief Summary in Lay Language

For the treatment of an acute lung disorder, the use of an extracorporeal membrane oxygenation (ECMO) - in addition to antiinfective treatment - might be necessary within the intensive care setting.

The ECMO takes over the lung function (and in some cases also the heart function). The blood of the patient will conitiuously be pumped through the artificial membrane lung (so called oxygenator) using a flexible tubing system. During this procedure, one cannot exclude, that single components of the ECMO might have a negative influence on the concentration of antiinfective drugs. This might lead to underdosing of the drugs that are important for the treatment of the underlying infection. Until now, these effects have not yet been studied in detail.

The aim of our study is to systematically analyse the behaviour of these drugs for the treatment of infections during ECMO.

Within the study, we will collect and analyse blood samples on three days within a time period of seven days and at the end of the ECMO-treatment. The blood samples will be taken using an already for the intensive care treatment routinely present central or peripheral catheter. Therefore no further punctions for the blood sampling are necessary.

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Brief Summary in Scientific Language

For the treatment of acute respiratory failure, extracorporeal membrane oxygenation (ECMO) is used in specialised hospitals. Until now, there are only limited data available regarding the pharmacokinetics of antiinfective drugs during ECMO in critically ill adults.
It is not yet known, whether absorption processes at the oxygenator membrane might influence drug concentrations, so that valid recommendations for drug dosing are not yet available.

Therefore the pharmacokinetics of different antiinfectives will be studied in critically ill adult patients.

Drug concentrations in serum samples will be analysed on a multiple-day basis. If applicable, drug concentrations will also be analysed in bronchoalveolar lavage specimens and correlated to the serum levels.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010765
  •   2016/09/09
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  •   yes
  •   Approved
  •   PV5223, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   J96.0 -  Acute respiratory failure
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Interventions/Observational Groups

  •   The pharmacokinetics of different antiinfective drugs (see primary endpoint) will be analysed systematically in adult patients treated with ECMO.

    Serum samples will be drawn on three days within a seven-day period after study inclusion. If antiinfectives are changed during ECMO, another set of serum samples will be obtained. First samples should be obtained as promptly as possible after the ECMO start.

    Data collection will be done until the Transfer of the Patient to another ward or until discharge (for the determination of length of stay) or until 28 days after admission to the intensive care unit (ICU) (for the determination of 28-day mortality).

    The concentrations of the antiinfectives will be measured using validated methods and further analysed using pharmacokinetic models.

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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of the study is the systematic evaluation of serum levels of different antiinfectives in critically ill patients undergoing ECMO treatment.
The main Focus is to Analyse, whether this special patient population is treated appropriately and whether the standard doses of antiinfectives are adequate and can be maintained.

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Secondary Outcome

- 28-days mortality, if the patient is treated as an inpatient in the UKE at that timepoint
- length of stay in the intensive care unit and in the hospital
- Progression parameter of infection markers (leucocytes, CRP, PCT)
- infections, that might be present due to potential underdosing of antiinfectives

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/25
  •   275
  •   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

Consecutive inclusion of adult patients (Age ≥ 18 years) of both genders, who need an ECMO and receive at least one of the following antiinfective drugs: anidulafungin, ceftazidime, ciprofloxacin, clarithromycin, colistin, linezolid, meropenem, piperacillin/tazobactam, posaconazole, tigecyclin, vancomycin or voriconazole.

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Exclusion Criteria

Age < 18 years
missing informed content

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Hamburg-EppendorfKlinik für Intensivmedizin
    • Mr.  Prof. Dr.  Stefan  Kluge 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfKlinikapothekeKlinik für Stammzelltransplantation
    • Ms.  PD Dr.  Claudia  Langebrake 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfKlinikapotheke
    • Ms.  Dzenefa  Alihodzic 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfKlinik für Intensivmedizin
    • Ms.  Dr.  Barbara  Sensen 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Hamburg-EppendorfKlinik für Intensivmedizin
    • Mr.  Prof. Dr.  Stefan  Kluge 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.