Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-01-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ventilator weaning first
Ventilator weaning first
Ventilator weaning initiated and completed before start of ECMO weaning.
ECMO weaning first
ECMO weaning first
ECMO weaning initiated and completed before start of ventilator weaning.
Interventions
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Ventilator weaning first
Ventilator weaning initiated and completed before start of ECMO weaning.
ECMO weaning first
ECMO weaning initiated and completed before start of ventilator weaning.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Peter Rosenberger, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tuebingen
Locations
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University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ECMOWean
Identifier Type: -
Identifier Source: org_study_id
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