Trial document




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  DRKS00015874

Trial Description

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Title

Reduction of ventilation invasiveness through combined organ support

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Trial Acronym

ADVOVENT (Advanced organ support for reduction of ventilation invasiveness)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Artificial ventilation is a life-saving standard method at intensive care units which although can lead to further damage of the lung tissue by the use of long-lasting or too invasive ventilation.
Patients with pulmonary failure can not release the excess carbon dioxide sufficiently, so that a more invasive ventilation is required to guarantee the carbon dioxide removal by the lung.
The aim of the clinical trial is to find out, if the invasiveness of artificial ventilation can be reduced by removing excess carbon dioxide directly from the blood.
For that purpose the ADVOS System will be used. It is a multiple organ support sytem, based on a conventional renal replacement therapy, which has also the potential to remove carbon dioxide from the blood.

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Brief Summary in Scientific Language

The invasive artificial ventilation is one of the life-saving standard methods at intensive care units which although can negatively affect the outcome of patients next to long-term application.
High ventilation pressures and high tidal volumes (and high concentrations of oxygen) can lead to further damage of the lung tissue respectively a progression of the organ failure.
The aim of the clinical trial is to achieve a reduction of the invasiveness of artificial ventilation by extracorporeal removal of carbon dioxide (CO2) and correction of acidosis via the advanced organ support (ADVOS) system.
Patients with acute renal failure (and indication for dialysis) and simultaneously acute hypercapnic respiratory failure should be included into the described study.
The applied ADVOS procedure is a multi-organ support system based on a continuous venovenous haemodialysis with an albumin-enriched dialysis liquid. It is extended by a cycle (with variable pH value) for albumin-cleaning and toxin-removal. By that the elimination of protein-bound substances and carbon dioxide is possible, as well an adjustment of the pH value within comparatively wide limits.

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Organizational Data

  •   DRKS00015874
  •   2018/11/13
  •   [---]*
  •   yes
  •   Approved
  •   D 526/18, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   J96 -  Respiratory failure, not elsewhere classified
  •   N17 -  Acute renal failure
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Interventions/Observational Groups

  •   removal of carbon dioxide (CO2) and correction of acidosis via ADVOS treatment
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   [---]*
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Primary Outcome

Tidal volume (ml/kg ideal weight) to reach a ventilation with a pH value >7,30 and PaCO2 < 60 mmHg (measured 6 hours after the beginning of the ADVOS treatment)

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Secondary Outcome

- CO2 removal achieved with the ADVOS system (ml/min)
- required alveolar ventilation per minute (l/min)
- pressure difference between airway plateau pressure and PEEP (cmH2O)
- change of power of ventilation (Joule/min)
- partial pressure of oxygen (mmHg)
- partial pressure of carbon dioxide (mmHg)
- pH

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/11/19
  •   10
  •   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

- invasive controlled ventilation at acute hypercapnic respiratory failure (PaCO2 > 45 mmHg)
- tidal volume > 6ml/kg ideal weight or driving pressure difference (delta p) > 15 cmH2O required to reach a pH value > 7,30
- acute renal failure (KDIGO II or III)
- clinical indication for continuous venovenous haemodialysis
- consent to participate in the clinical trial

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Exclusion Criteria

- severe acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 100 mmHg)
- moribund status (clinical evaluation)
- gravidity
- severe haemodynamic instability (heart rate < 40 bpm or > 150 bpm or mean arterial pressure < 65 mmHg or cardiac output < 5 l/min despite adequate therapy)
- elevated intracranial pressure

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Addresses

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    • Universitätsklinikum Schleswig-Holstein
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    •   [---]*
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    •   [---]*
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    • Klinik für Anästhesiologie und operative Intensivmedizin, Universtitätsklinikum Schleswig Holstein, Campus Kiel
    • Mr.  Dr.med.  Lars  Hummitzsch 
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    • Klinik für Anästhesiologie und operative Intensivmedizin, Universtitätsklinikum Schleswig Holstein, Campus Kiel
    • Mr.  Dr.med.  Lars  Hummitzsch 
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und operative Intensivmedizin
    • Arnold-Heller-Strasse 3
    • 24105  Kiel
    • Germany
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    • HepaWash GmbH
    • Agnes-Pockels-Bogen 1
    • 80992  München
    • Germany
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Status

  •   Recruiting planned
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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.