Inflammation During ECMO Therapy and ECMO Weaning

NCT05640635 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Tuebingen

Phase

Not applicable

Started

2023-01-01

Last updated

2024-06-24

Condition(s) studied

Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Ventilator weaning firstECMO weaning first

Ventilator weaning first: Ventilator weaning initiated and completed before start of ECMO weaning.

ECMO weaning first: ECMO weaning initiated and completed before start of ventilator weaning.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

IL-6 concentration (blood samples) — For the duration of the ICU stay, or a maximum of 60 days.
Daily control of above mentioned parameter.

Trial sites (1)

Facility	City	Region	Status
University Hospital Tuebingen	Tübingen	Baden-Wurttemberg	Recruiting

More University Hospital Tuebingen trials in Germany

A Strong Start in Life - ELAS 2.0: A Digital Learning Program to Promote a Healthy Pregnancy and Early Child Protection Starting soon

Identification of Risk Factors, Exposomics and Genetic Susceptibility of Melanoma in Children, Adolescents and Young Adults Recruiting

PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes Recruiting

The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4 Recruiting

Feasibility of Online MR-guided Radiotherapy on a 1.5T MR-Linac Recruiting

Other trials for the same condition

Reduction of Blood Recirculation in Veno-Venous ECMO Recruiting

CytOSorb TreatMent Of Critically Ill PatientS Registry Recruiting

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) Recruiting

Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05640635 on ClinicalTrials.gov ↗ ← All trials in Germany