Inflammation During ECMO Therapy and ECMO Weaning

NCT ID: NCT05640635

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ventilator weaning first

Group Type ACTIVE_COMPARATOR

Ventilator weaning first

Intervention Type PROCEDURE

Ventilator weaning initiated and completed before start of ECMO weaning.

ECMO weaning first

Group Type ACTIVE_COMPARATOR

ECMO weaning first

Intervention Type PROCEDURE

ECMO weaning initiated and completed before start of ventilator weaning.

Interventions

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Ventilator weaning first

Ventilator weaning initiated and completed before start of ECMO weaning.

Intervention Type PROCEDURE

ECMO weaning first

ECMO weaning initiated and completed before start of ventilator weaning.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Rosenberger, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter Rosenberger, Prof.

Role: CONTACT

+49707129 ext. 86622

Facility Contacts

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Peter Rosenberger, Prof. Dr.

Role: primary

Alice Bernard, Dr.

Role: backup

Other Identifiers

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ECMOWean

Identifier Type: -

Identifier Source: org_study_id

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