Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05640635

Inflammation During ECMO Therapy and ECMO Weaning

Led by University Hospital Tuebingen · Updated on 2024-06-24

40

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Inflammation During ECMO Therapy and ECMO Weaning

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or improved during the last 24 hours
  • Tidal volume did not change or improved during the last 24 hours with a PEEP of 10 cmH2O or above
  • Consent of the patient or their legal representative
Not Eligible

You will not qualify if you...

  • Age under 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

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Research Team

P

Peter Rosenberger, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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