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Inflammation During ECMO Therapy and ECMO Weaning (ECMOWean)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ventilator weaning first
ECMO weaning first
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, Extracorporal membrane oxygenation, Extracorporal membrane oxygenation weaning, Ventilation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ventilator weaning first

    ECMO weaning first

    Arm Description

    Outcomes

    Primary Outcome Measures

    IL-6 concentration (blood samples)
    Daily control of above mentioned parameter.

    Secondary Outcome Measures

    SOFA-Score
    Sequential organ failure assessement score evaluated at days 1-14, 28, and 60.
    Ventilation pressures
    Pressures applied to the lung during artificial ventilation
    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)
    Length of stay in the intensive care unit
    Length of stay in the intensive care unit.
    Ventilator-associated pneumonia
    Occurence/incidence of ventilator-associated pneumonia.
    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.
    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.

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    November 28, 2022
    Sponsor
    University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05640635
    Brief Title
    Inflammation During ECMO Therapy and ECMO Weaning
    Acronym
    ECMOWean
    Official Title
    Inflammation During ECMO Therapy and ECMO Weaning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Distress Syndrome
    Keywords
    Acute Respiratory Distress Syndrome, Extracorporal membrane oxygenation, Extracorporal membrane oxygenation weaning, Ventilation therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Rosenberger, Prof.
    Phone
    +49707129
    Ext
    86622
    Email
    peter.rosenberger@med.uni-tuebingen.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Rosenberger, Prof.
    Organizational Affiliation
    University Hospital Tuebingen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Inflammation During ECMO Therapy and ECMO Weaning

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