ARDS, HumanECMO-VIDNCT04341285
Early Versus Late ECMO Therapy in COVID-19 Induced ARDS (ECMO-VID)
A study testing ECMO Implantation in people with ARDS, Human and COVID-19, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, COVID-19
- What is being tested?
- ECMO Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- COVID-19positive(+) ARDS as defined according to the Berlin Definition
- ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaO2/ FiO2) ≤100
- Bilateral opacities consistent with pulmonary edema on frontal chest radiograph
- requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
- no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
- ≤ 7 days from the initiation of mechanical ventilation at the time of randomization. - Patients must be enrolled within 96 hours of onset of ARDS -
Who cannot join
- COVID-19negative(-) ARDS
- Age less than 18 years
- More than 7 days since initiation of mechanical ventilation
- more than 96 hours since meeting ARDS criteria
- patient, surrogate or physician not committed to full intensive care support.
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit.
Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias.
Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers
Read the detailed description
The severe form of COVID-19 infection is characterized and marked by severe pneumonia and the Acute Respiratory Distress Syndrome (ARDS). ARDS is characterized by the loss of pulmonary tissue compliance and severe hypoxia. The central pathophysiologic changes of COVID-19+ ARDS are dysregulated inflammation within the alveolar space and altered permeability of the alveolar-capillary barrier. The public health impact of this COVID-19+ ARDS is considerable with a large number of ARDS cases that need to be treated currently on German Intensive Care Units. To date, the associated mortality ranges between 30 to 50%. In the ongoing COVID-19 crisis cases of ARDS will still increase and pose a significant challenge to the German Medical System. Despite the emerging understanding of COVID-19+ ARDS, treatment only remains to be symptomatic using mechanical ventilation, prone positioning and in severe cases of hypoxia extracorporal membrane oxygenation (ECMO). Current evidence generated by clinical trials demonstrates that patients with ARDS should be referred to a specialized center to receive expert treatment. The use of ECMO might have a beneficial effect on overall patient outcome, yet this has not been proven by clinical trials and to date ECMO is recommended as measure of last resort in the current ARDS treatment guidelines. The timing of ECMO placement to relieve hypoxia is an important question for the treating clinician but is not well studied to date. This might also have impact on the long-term functional outcome of patients. In addition, evidence about the role of ECMO in the outcome of COVID-19+ patients might have significant impact on the referral of patients to a specialized center and is important for the treating physician. Therefore, the investigators want to pursue the questions whether early ECMO placement is superior than the placement of ECMO as a rescue measure, and whether this could result in improved overall outcome of patients with COVID-19+ ARDS.
- Conditions
- ARDS, Human, COVID-19
- Being tested
- ECMO Implantation
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO ImplantationProcedure or surgery
Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit.
| Study group | Role | What they receive |
|---|---|---|
| Early ECMO | Active comparator | Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Receives: Procedure: ECMO Implantation |
| Late ECMO | Active comparator | Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Receives: Procedure: ECMO Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day all cause mortality
survival in 28-day follow-up period (28 day all cause mortality)
Measured: 28 Days
Secondary outcomes (7)
90 day all cause mortality
90 day all cause mortality
Measured: 90 days
Sepsis-related organ failure assessment score at day 1-14, 28 and 90 days
Sepsis-related organ failure assessment score at day 1-14, 28 and 90 days
Measured: day 1-14, 28 and 90
duration of mechanical ventilation support
duration of mechanical ventilation support
Measured: 28 days
Ventilator Associated Pneumonia
Number of patients with Ventilator Associated Pneumonia
Measured: 28 days
Bleeding complications
number of blood transfusion units
Measured: 28 das
Acute Renal Failure
Days on real replacement therapy
Measured: 28 days
Discharge Location
Discharge to (home, skilled nursing facility, rehabilitation)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Why it stopped: study protocol was changed to include non-COVID patients and registered under a different ID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Model description
- Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: 90days or until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg, RWTH Aachen University, University Hospital Muenster
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, Prof., Principal investigator, +4970712986622
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341285
- Sponsor's protocol ID
- ECMO-VID
- Acronym
- ECMO-VID
- Status last verified
- Jun 2020
- First submitted
- 30 Mar 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late ECMO Therapy in COVID-19 Induced ARDS (ECMO-VID)
- ClinicalTrials.gov ID
- NCT04341285
- Acronym / sponsor ID
- ECMO-VID / ECMO-VID
- Conditions
- ARDS, Human, COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study protocol was changed to include non-COVID patients and registered under a different ID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Freiburg, RWTH Aachen University, University Hospital Muenster
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 10 Apr 2020 (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.
Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit.
Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias.
Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers
Detailed description
The severe form of COVID-19 infection is characterized and marked by severe pneumonia and the Acute Respiratory Distress Syndrome (ARDS). ARDS is characterized by the loss of pulmonary tissue compliance and severe hypoxia. The central pathophysiologic changes of COVID-19+ ARDS are dysregulated inflammation within the alveolar space and altered permeability of the alveolar-capillary barrier. The public health impact of this COVID-19+ ARDS is considerable with a large number of ARDS cases that need to be treated currently on German Intensive Care Units. To date, the associated mortality ranges between 30 to 50%. In the ongoing COVID-19 crisis cases of ARDS will still increase and pose a significant challenge to the German Medical System. Despite the emerging understanding of COVID-19+ ARDS, treatment only remains to be symptomatic using mechanical ventilation, prone positioning and in severe cases of hypoxia extracorporal membrane oxygenation (ECMO). Current evidence generated by clinical trials demonstrates that patients with ARDS should be referred to a specialized center to receive expert treatment. The use of ECMO might have a beneficial effect on overall patient outcome, yet this has not been proven by clinical trials and to date ECMO is recommended as measure of last resort in the current ARDS treatment guidelines. The timing of ECMO placement to relieve hypoxia is an important question for the treating clinician but is not well studied to date. This might also have impact on the long-term functional outcome of patients. In addition, evidence about the role of ECMO in the outcome of COVID-19+ patients might have significant impact on the referral of patients to a specialized center and is important for the treating physician. Therefore, the investigators want to pursue the questions whether early ECMO placement is superior than the placement of ECMO as a rescue measure, and whether this could result in improved overall outcome of patients with COVID-19+ ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: 90days or until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers
| Arm | Type | Receives |
|---|---|---|
| Early ECMO | Active comparator | Procedure: ECMO ImplantationExperimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. |
| Late ECMO | Active comparator | Procedure: ECMO ImplantationInsertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- COVID-19positive(+) ARDS as defined according to the Berlin Definition
- ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaO2/ FiO2) ≤100
- Bilateral opacities consistent with pulmonary edema on frontal chest radiograph
- requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
- no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
Key exclusion criteria (6 listed)
- COVID-19negative(-) ARDS
- Age less than 18 years
- More than 7 days since initiation of mechanical ventilation
- more than 96 hours since meeting ARDS criteria
- patient, surrogate or physician not committed to full intensive care support.
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 |
|---|---|---|
| ECMO ImplantationInsertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. | Procedure or surgery | Early ECMO, Late ECMO |
Primary outcome
28 day all cause mortality
Time frame: 28 Days
survival in 28-day follow-up period (28 day all cause mortality)
7 secondary outcomes
90 day all cause mortality
Time frame: 90 days
Sepsis-related organ failure assessment score at day 1-14, 28 and 90 days
Time frame: day 1-14, 28 and 90
duration of mechanical ventilation support
Time frame: 28 days
Ventilator Associated Pneumonia
Time frame: 28 days
Bleeding complications
Time frame: 28 das
Acute Renal Failure
Time frame: 28 days
Discharge Location
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Peter Rosenberger, Prof. principal investigator
+4970712986622
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECMO Implantation in people with ARDS, Human and COVID-19, 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 6 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: withdrawn, as of the sponsor's last update on 9 Jun 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day all cause mortality (time frame: 28 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 9 Jun 2021.