The goal of this interventional clinical trial is to compare patients who undergo ECMO therapy for treatment of acute respiratory distress syndrome (ARDS) and a randomized into one of two possible weaning strategy groups. Group 1: Weaning from ventilator occurs before ECMO weaning. Group 2: Weaning from ECMO occurs before weaning from ventilator. This study investigates which one of these strategies is more indulgent for the lung, and leads to less inflammation and therefore less potential side effects and an overall more favourable clinical course. As a primary criterion, measure of IL-6 in blood samples will beused. As secondary criterions, SOFA score at various time points, ventilation pressures, lung injury score (LIS), length of stay in the intensive care unit, and ventilator-associated pneumonia as well as levels of inflammatory cells and cytokines in both blood samples and bronchoalveolar lavage at different time points will be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Ventilator weaning initiated and completed before start of ECMO weaning.
ECMO weaning initiated and completed before start of ventilator weaning.
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGIL-6 concentration (blood samples)
Daily control of above mentioned parameter.
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
SOFA-Score
Sequential organ failure assessement score evaluated at days 1-14, 28, and 60.
Time frame: For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..
Ventilation pressures
Pressures applied to the lung during artificial ventilation
Time frame: For the duration of the artificial ventilation, or a maximum of 60 days.
Murray Lung Injury Score (LIS)
Assessement of severity of lung damage by the established Lung Injury Score by Murray (Min Value is 0, healthy and Max Value is 20, severly diseased)
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
Length of stay in the intensive care unit
Length of stay in the intensive care unit.
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
Ventilator-associated pneumonia
Occurence/incidence of ventilator-associated pneumonia.
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha)
Collection of blood samples at various times points for further analysis.
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha)
Collection of bronchoalveolar lavage samples at various times points for further analysis.
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
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