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Recruiting NCT05640635

Inflammation During ECMO Therapy and ECMO Weaning

No phase Interventional Acute Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ventilator weaning first, ECMO weaning first.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • IL-6 concentration (blood samples) [Time frame: For the duration of the ICU stay, or a maximum of 60 days.]
Secondary outcome measures (7)
  • SOFA-Score [Time frame: For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..]
  • Ventilation pressures [Time frame: For the duration of the artificial ventilation, or a maximum of 60 days.]
  • Murray Lung Injury Score (LIS) [Time frame: For the duration of the ICU stay, or a maximum of 60 days.]
  • Length of stay in the intensive care unit [Time frame: For the duration of the ICU stay, or a maximum of 60 days.]
  • Ventilator-associated pneumonia [Time frame: 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) [Time frame: 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) [Time frame: For the duration of the ICU stay, or a maximum of 60 days.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Hospital Tuebingen — Tübingen

Identifiers

NCT: NCT05640635 · ECMOWean

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗