Clinical trial NCT05640635: Inflammation During ECMO Therapy and ECMO Weaning
Official title: Inflammation During ECMO Therapy and ECMO Weaning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
Extracorporal membrane oxygenation
Extracorporal membrane oxygenation weaning
Ventilation therapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: IL-6 concentration (blood samples)
timeFrame: For the duration of the ICU stay, or a maximum of 60 days.
Secondary outcomes:
measure: SOFA-Score
timeFrame: For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..
measure: Ventilation pressures
timeFrame: For the duration of the artificial ventilation, or a maximum of 60 days.
measure: Murray Lung Injury Score (LIS)
timeFrame: For the duration of the ICU stay, or a maximum of 60 days.
measure: Length of stay in the intensive care unit
timeFrame: For the duration of the ICU stay, or a maximum of 60 days.
measure: Ventilator-associated pneumonia
timeFrame: For the duration of the ICU stay, or a maximum of 60 days.
measure: Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha)
timeFrame: For the duration of the ICU stay, or a maximum of 60 days.
measure: Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha)
timeFrame: For the duration of the ICU stay, or a maximum of 60 days.
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Wuerttemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Peter Rosenberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References: