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NCT Number: NCT05640635

Inflammation During ECMO Therapy and ECMO Weaning

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location status: Recruiting

Location contact

Alice Bernard, Dr.

CONTACT

[email protected]

Peter Rosenberger, Prof. Dr.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilator weaning first

Procedure

Ventilator weaning initiated and completed before start of ECMO weaning.

ECMO weaning first

Procedure

ECMO weaning initiated and completed before start of ventilator weaning.

Primary outcomes

  1. IL-6 concentration (blood samples)

    Time frame: For the duration of the ICU stay, or a maximum of 60 days.

    Daily control of above mentioned parameter.

Secondary outcomes

  1. SOFA-Score

    Time frame: 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.

  2. Ventilation pressures

    Time frame: For the duration of the artificial ventilation, or a maximum of 60 days.

    Pressures applied to the lung during artificial ventilation

  3. Murray Lung Injury Score (LIS)

    Time frame: 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)

  4. Length of stay in the intensive care unit

    Time frame: For the duration of the ICU stay, or a maximum of 60 days.

    Length of stay in the intensive care unit.

  5. Ventilator-associated pneumonia

    Time frame: For the duration of the ICU stay, or a maximum of 60 days.

    Occurence/incidence of ventilator-associated pneumonia.

  6. Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha)

    Time frame: For the duration of the ICU stay, or a maximum of 60 days.

    Collection of blood samples at various times points for further analysis.

  7. Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Rosenberger, Prof.

CONTACT

[email protected]

+49707129 ext. 86622

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: ECMOWean

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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