Acute Respiratory Distress SyndromeECMOWeanNCT05640635
Inflammation During ECMO Therapy and ECMO Weaning
A study testing Ventilator weaning first and ECMO weaning first in people with Acute Respiratory Distress Syndrome, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Ventilator weaning first and ECMO weaning first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Peter Rosenberger, Prof. Dr., peter.rosenberger@med.uni-tuebingen.de
Alice Bernard, Dr., alice.bernard@med.uni-tuebingen.de
About this study
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.
Read more
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
- Acute Respiratory Distress Syndrome
- Being tested
- Ventilator weaning first, ECMO weaning first
- Keywords
- Acute Respiratory Distress Syndrome, Extracorporal membrane oxygenation, Extracorporal membrane oxygenation weaning, Ventilation therapy
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator weaning firstProcedure or surgery
Ventilator weaning initiated and completed before start of ECMO weaning.
ECMO weaning firstProcedure or surgery
ECMO weaning initiated and completed before start of ventilator weaning.
| Study group | Role | What they receive |
|---|---|---|
| Ventilator weaning first | Active comparator | Not described Receives: Procedure: Ventilator weaning first |
| ECMO weaning first | Active comparator | Not described Receives: Procedure: ECMO weaning first |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 concentration (blood samples)
Daily control of above mentioned parameter.
Measured: For the duration of the ICU stay, or a maximum of 60 days.
Secondary outcomes (7)
SOFA-Score
Sequential organ failure assessement score evaluated at days 1-14, 28, and 60.
Measured: For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..
Ventilation pressures
Pressures applied to the lung during artificial ventilation
Measured: For the duration of the artificial ventilation, or a maximum of 60 days.
Murray Lung Injury Score (LIS)
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)
Measured: For the duration of the ICU stay, or a maximum of 60 days.
Length of stay in the intensive care unit
Length of stay in the intensive care unit.
Measured: For the duration of the ICU stay, or a maximum of 60 days.
Ventilator-associated pneumonia
Occurence/incidence of ventilator-associated pneumonia.
Measured: 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)
Collection of blood samples at various times points for further analysis.
Measured: 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)
Collection of bronchoalveolar lavage samples at various times points for further analysis.
Measured: For the duration of the ICU stay, or a maximum of 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2023
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640635
- Sponsor's protocol ID
- ECMOWean
- Acronym
- ECMOWean
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation During ECMO Therapy and ECMO Weaning
- ClinicalTrials.gov ID
- NCT05640635
- Acronym / sponsor ID
- ECMOWean / ECMOWean
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Extracorporal membrane oxygenation, Extracorporal membrane oxygenation weaning, Ventilation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilator weaning first | Active comparator | Procedure: Ventilator weaning first |
| ECMO weaning first | Active comparator | Procedure: ECMO weaning first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator weaning firstVentilator weaning initiated and completed before start of ECMO weaning. | Procedure or surgery | Ventilator weaning first |
| ECMO weaning firstECMO weaning initiated and completed before start of ventilator weaning. | Procedure or surgery | ECMO weaning first |
Primary outcome
IL-6 concentration (blood samples)
Time frame: For the duration of the ICU stay, or a maximum of 60 days.
Daily control of above mentioned parameter.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Rosenberger, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator weaning first and ECMO weaning first in people with Acute Respiratory Distress Syndrome, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Rosenberger, Prof. (+49707129 ext. 86622, peter.rosenberger@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 concentration (blood samples) (time frame: For the duration of the ICU stay, or a maximum of 60 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.