Inflammation During ECMO Therapy and ECMO Weaning (ECMOWean)

University Hospital Tuebingen

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome

Treatments: Procedure: ECMO weaning first; Procedure: Ventilator weaning first

Study type: Interventional

Funder types: Other

Identifiers

NCT05640635

ECMOWean

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ventilator weaning first

Active Comparator group

Treatment:

Procedure: Ventilator weaning first

ECMO weaning first

Active Comparator group

Treatment:

Procedure: ECMO weaning first