Comparing weaning strategies during ECMO therapy for ARDS
Inflammation During ECMO Therapy and ECMO Weaning
This study is testing two different ways to help patients with severe lung problems on ECMO therapy breathe better by seeing if it's better to wean them off the ventilator first or the ECMO machine first.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Trial ID | NCT05640635 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two different weaning strategies for patients undergoing ECMO therapy for acute respiratory distress syndrome (ARDS). Participants will be randomized into one of two groups: one group will wean from the ventilator before ECMO, while the other will wean from ECMO before the ventilator. The study will assess which strategy results in less lung inflammation and better clinical outcomes. Key measurements will include IL-6 levels in blood samples, SOFA scores, lung injury scores, and other indicators of lung function and inflammation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with acute respiratory distress syndrome requiring veno-venous ECMO who are hemodynamically stable.
Not a fit: Patients under 18 years old or those with chronic respiratory insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved weaning strategies that minimize lung inflammation and enhance recovery for ARDS patients on ECMO.
How similar studies have performed: While similar studies have explored ECMO and ventilation strategies, this specific comparison of weaning order is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tübingen, Baden-Wurttemberg
- University Hospital Tuebingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Rosenberger, Prof. — University Hospital Tuebingen
- Study coordinator: Peter Rosenberger, Prof.
- Email: peter.rosenberger@med.uni-tuebingen.de
- Phone: +49707129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.