ECMOWean: Inflammation During ECMO Therapy and ECMO Weaning

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640635

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Procedure: Ventilator weaning first Procedure: ECMO weaning first	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Inflammation During ECMO Therapy and ECMO Weaning

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ventilator weaning first	Procedure: Ventilator weaning first Ventilator weaning initiated and completed before start of ECMO weaning.
Active Comparator: ECMO weaning first	Procedure: ECMO weaning first ECMO weaning initiated and completed before start of ventilator weaning.

Arm

Intervention/Treatment

Active Comparator: Ventilator weaning first

Procedure: Ventilator weaning first

Ventilator weaning initiated and completed before start of ECMO weaning.

Active Comparator: ECMO weaning first

Procedure: ECMO weaning first

ECMO weaning initiated and completed before start of ventilator weaning.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

SOFA-Score [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.
Ventilation pressures [For the duration of the artificial ventilation, or a maximum of 60 days.]
Pressures applied to the lung during artificial ventilation
Murray Lung Injury Score (LIS) [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)
Length of stay in the intensive care unit [For the duration of the ICU stay, or a maximum of 60 days.]
Length of stay in the intensive care unit.
Ventilator-associated pneumonia [For the duration of the ICU stay, or a maximum of 60 days.]
Occurence/incidence of ventilator-associated pneumonia.
Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha) [For the duration of the ICU stay, or a maximum of 60 days.]
Collection of blood samples at various times points for further analysis.
Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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