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Inflammation During ECMO Therapy and ECMO Weaning

RecruitingNAAges 18 Years - anyAllUniversity Hospital Tuebingen
NCT05640635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 bro

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📋 Eligibility rules (as published)
Inclusion Criteria: * Acute respiratory distress syndrome (ARDS) according to the Berlin Definition (PaO2/FiO2 \< 100) and treatment with veno-venous ECMO (vvECMO) * Hemodynamic stability * Lung compliance did not change/improved during the last 24 hours * Tidal volume did not change/improved during the last 24 hours with a PEEP of 10 cmH20 or above * Consent of the patient or their legal representative Exclusion Criteria: * Age \< 18 years * Artificial ventilation for more than 7 days prior * Patient, legal representative or doctors decided against an unrestricted intensive care treatment * Positive pregnancy test at time of screening * Cardiac failure requiring veno-arterial ECMO therapy * Chronic respiratory insufficiency requiring long-term oxygen treatment
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What it tests

  • Ventilator weaning first
  • ECMO weaning first
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Where

1 site
University Hospital Tuebingen
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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