Inflammation During ECMO Therapy and ECMO Weaning

Acute Respiratory Distress Syndrome Clinical Trial

— ECMOWean  

Official title:

Inflammation During ECMO Therapy and ECMO Weaning

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05640635
• Other study ID #: ECMOWean
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: November 2022
• Source: University Hospital Tuebingen
• Contact: Peter Rosenberger, Prof.
• Phone: +49707129
• Email: peter.rosenberger[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Inflammation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Ventilator weaning first
Ventilator weaning initiated and completed before start of ECMO weaning.
• ECMO weaning first
ECMO weaning initiated and completed before start of ventilator weaning.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6 concentration (blood samples)	Daily control of above mentioned parameter.	For the duration of the ICU stay, or a maximum of 60 days.
Secondary	SOFA-Score	Sequential organ failure assessement score evaluated at days 1-14, 28, and 60.	For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..
Secondary	Ventilation pressures	Pressures applied to the lung during artificial ventilation	For the duration of the artificial ventilation, or a maximum of 60 days.
Secondary	Murray Lung Injury Score (LIS)	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)	For the duration of the ICU stay, or a maximum of 60 days.
Secondary	Length of stay in the intensive care unit	Length of stay in the intensive care unit.	For the duration of the ICU stay, or a maximum of 60 days.
Secondary	Ventilator-associated pneumonia	Occurence/incidence of ventilator-associated pneumonia.	For the duration of the ICU stay, or a maximum of 60 days.
Secondary	Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha)	Collection of blood samples at various times points for further analysis.	For the duration of the ICU stay, or a maximum of 60 days.
Secondary	Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha)	Collection of bronchoalveolar lavage samples at various times points for further analysis.	For the duration of the ICU stay, or a maximum of 60 days.