Inflammation During ECMO Therapy and ECMO Weaning

Recruiting now · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT05640635

Run by

University Hospital Tuebingen

People needed

40

Starts

2023-01-01

Expected to finish

2026-12-01

Last updated by the study team

2024-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital Tuebingen — Tübingen, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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