Trial document





This trial has been registered retrospectively.
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  DRKS00005106

Trial Description

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Title

Quantification of recirculation during veno-venous extracorporeal membrane oxygenation (VV-ECMO) in severe respiratory insufficiency

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Veno-venous extracorporeal membrane oxygenation (VV ECMO) is a proven technique to support the treatment of the adult respiratory distress syndrome (ARDS). This supportive technique which can be seen as a modified heart lung machine allows reducing the stressful mechanical ventilation and a recovery of lung tissue.
The placement of the ECMO related cannula in the venous system leads to a recirculation of the oxygenated blood. An adequate positioning of the cannula to minimize recirculation is currently impossible as the recirculation can only be roughly estimated. It is thought that only 60 -80% of the blood is available for oxygen delivery to the patients.
With this prospective observational study in patients with VV ECMO the recirculation fraction should be quantified to allow an adequate cannula position and to maximize the efficiency of the ECMO system.

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Brief Summary in Scientific Language

Background.
Recirculation during veno-venous ECMO (VV ECMO) is a multifactorial event which results in a variable fraction of oxygenated blood flowing back into the draining cannula due to the proximity of draining and delivering cannula. Several authors reported this fraction to be as high as 50%. It is thought to cause a clinically relevant reduced oxygen delivery (DO2) to the patient. Techniques with the capability to quantify the recirculation fraction are practically not available for routine use and have not been validated so far in adults. Previous articles were mainly focused on the measurement of recirculation in children and on the mathematical approximation of this event. Quantifiable results to support the hypothesized reduced oxygen delivery have not been published so far.
Study design.
To evaluate the clinical relevance of recirculation we plan to conduct a prospective observational study which should include all adult patients in our hospital requiring veno-venous ECMO between May 2012 and April 2014. We anticipate enrolling a group of 15–20 pati¬ents. The measurement of recirculation is based on ultrasound dilution technique, cardiac output measurement and with the calculation of oxygen consumption (VO2) and delivery (DO2). We plan to investigate whether an increasing recirculation fraction is associated with a decrea¬sing oxygen delivery and arterial oxygen saturation of the patients as a primary clinical endpoint. It is further assessed whether the recircula-tion fraction differs markedly due to a varying cardiac output. We hypothesize that recirculation irrespective of its magnitude does not affect the arterial oxygen saturation of the patients.

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Organizational Data

  •   DRKS00005106
  •   2013/06/25
  •   [---]*
  •   yes
  •   Approved
  •   22/12, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  •   U1111-1144-9840 
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Health Condition or Problem studied

  •   J80 -  Adult respiratory distress syndrome
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Interventions/Observational Groups

  •   The impact of recirculation, cardiac output and cannula position on oxygen delivery and arterial oxygen saturation as clinical endpoint should be daily assessed in patients with adult respiratory distress syndrome supported by a veno-venous ECMO.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Arterial oxygen Saturation, Oxygen delivery, Recirculation fraction

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Secondary Outcome

Position of ECMO cannula, patient cardiac output

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/03
  •   20
  •   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 which requires vv ECMO during ARDS and which gives written voluntary consent during ECMO

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Exclusion Criteria

Unability to obtain written voluntary consent until end of vv ECMO

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Addresses

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    • Universitätsklinikum Gießen und Marburg
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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    • Klinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  Prof. Dr. med  Andreas  Böning 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
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    • Klinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  Prof. Dr. med  Andreas  Böning 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  Prof. Dr. med  Andreas  Böning 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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