Actively Recruiting
Inflammation During ECMO Therapy and ECMO Weaning
Led by University Hospital Tuebingen · Updated on 2024-06-24
40
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inflammation During ECMO Therapy and ECMO Weaning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or improved during the last 24 hours
- Tidal volume did not change or improved during the last 24 hours with a PEEP of 10 cmH2O or above
- Consent of the patient or their legal representative
You will not qualify if you...
- Age under 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
P
Peter Rosenberger, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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