Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Respiratory Distress Syndrome, Extracorporal membrane oxygenation, Extracorporal membrane oxygenation weaning, Ventilation therapy
Brief summary
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.
Interventions
PROCEDUREVentilator weaning first
Ventilator weaning initiated and completed before start of ECMO weaning.
PROCEDUREECMO weaning first
ECMO weaning initiated and completed before start of ventilator weaning.
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 concentration (blood samples) | For the duration of the ICU stay, or a maximum of 60 days. | Daily control of above mentioned parameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA-Score | For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above.. | Sequential organ failure assessement score evaluated at days 1-14, 28, and 60. |
| Murray Lung Injury Score (LIS) | For the duration of the ICU stay, or a maximum of 60 days. | Assessement of severity of lung damage by the established Lung Injury Score by Murray (Min Value is 0, healthy and Max Value is 20, severly diseased) |
| Length of stay in the intensive care unit | For the duration of the ICU stay, or a maximum of 60 days. | Length of stay in the intensive care unit. |
| Ventilation pressures | For the duration of the artificial ventilation, or a maximum of 60 days. | Pressures applied to the lung during artificial ventilation |
| Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha) | For the duration of the ICU stay, or a maximum of 60 days. | Collection of blood samples at various times points for further analysis. |
| Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha) | For the duration of the ICU stay, or a maximum of 60 days. | Collection of bronchoalveolar lavage samples at various times points for further analysis. |
| Ventilator-associated pneumonia | For the duration of the ICU stay, or a maximum of 60 days. | Occurence/incidence of ventilator-associated pneumonia. |
Countries
Germany
Contacts
Primary ContactPeter Rosenberger, Prof.
Outcome results
None listed