Inflammation During ECMO Therapy and ECMO Weaning (ECMOWean)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: Ventilator weaning first; Procedure: ECMO weaning first

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Rosenberger, Prof.; Phone Number: 86622 +49707129; Email: peter.rosenberger@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • Recruiting
      • University Hospital Tuebingen
      • Contact: Peter Rosenberger, Prof. Dr.; Email: peter.rosenberger@med.uni-tuebingen.de
      • Contact: Alice Bernard, Dr.; Email: alice.bernard@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ventilator weaning first	Procedure: Ventilator weaning first; Ventilator weaning initiated and completed before start of ECMO weaning.
Active Comparator: ECMO weaning first	Procedure: ECMO weaning first; ECMO weaning initiated and completed before start of ventilator weaning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..
Ventilation pressures	Pressures applied to the lung during artificial ventilation	For the duration of the artificial ventilation, or a maximum of 60 days.
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.
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.
Ventilator-associated pneumonia	Occurence/incidence of ventilator-associated pneumonia.	For the duration of the ICU stay, or a maximum of 60 days.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Peter Rosenberger, Prof., University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; Extracorporal membrane oxygenation; Extracorporal membrane oxygenation weaning; Ventilation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Inflammation; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ECMOWean

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No