ARDS Due to Disease Caused by SARS Co-V-2ECMOPred-vvvaNCT05910996
Prediction of Conversion From Vv-ECMO to Va-ECMO in COVID-19 Patients
An observational study of ARDS Due to Disease Caused by SARS Co-V-2, run by Kepler University Hospital at 1 site in Austria.
Trial summary
In December 2019, cases of a novel lung disease, later referred to as COVID-19, were first reported in China. The virus SARS-CoV-2 was identified as the causative agent. Due to the sharp increase in the number of cases worldwide, a pandemic outbreak was declared by WHO in March 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS Due to Disease Caused by SARS Co-V-2
- What is being tested?
- Conversion from vv-ECMO to va-ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteAustria
- Study dates
- 30 Sep 2023to 31 Dec 2023
- Phase
- Observational
- 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
Study population: As described in the inclusion criteria.
Who may be able to join
- COVID-19 positive patients aged 18 years or older that were treated in intensive care at the study center between 2019-12-01 and 2023-04-15.
Who cannot join
- Patients in which ECMO therapy was started outside of the study center.
Trial locations and contacts
1 site in 1 country.
About this study
In December 2019, cases of a novel lung disease, later referred to as COVID-19, were first reported in China. The virus SARS-CoV-2 was identified as the causative agent. Due to the sharp increase in the number of cases worldwide, a pandemic outbreak was declared by WHO in March 2020.
The infection presents with a broad clinical spectrum. Frequently, there is respiratory infection with fever (80%), dry cough (56%), fatigue (22%), and muscle pain (7%), but completely asymptomatic infection is also possible. Severe courses may be associated with pneumonia resulting in acute respiratory distress syndrome (ARDS) requiring intensive care.
Read more
In the context of intensive care therapy, it is sometimes necessary to use extracorporeal organ replacement procedures due to increasing lung failure. In this context, extracorporeal membrane oxygenation (ECMO) was used during the pandemic. With this procedure it is possible to replace on the one hand the oxygenation and ventilation function of the lung and on the other hand additionally the pumping function of the heart, if configured appropriately. The switch from venovenous (vv) configuration, with which only lung function is replaced, to venoarterial (va) configuration (lung function and heart function are replaced) is made in cases of intensive care necessity, e.g., increasing decompensation of heart failure.
Heart failure manifests itself, among other things, through insufficient pumping function of the heart muscle. This results in an undersupply of peripheral tissues with arterial blood, leading to increased anaerobic glycolysis. Lactate and B-type natriuretic peptide (BNP) are used as surrogate parameters of this undersupply. Increased oxygen depletion from oxygen available in arterial blood is detected by the surrogate parameter central venous oxygen saturation (ScvO2).
In addition to ECMO, drug interventions are also used to improve cardiorespiratory performance at various doses. As described by Suwalski et al, there may be a relationship between this drug therapy and conversion from vv to va ECMO.
Currently, few studies exist on conversion from vv-ECMO to va-ECMO. In this regard, Suwalski et al. describe a population that experienced any ECMO therapy for a maximum period of 16.5 ± 10.0 days, with the group with conversion receiving 17.8 ± 10.5 days of therapy and the group without conversion receiving 16.4 ± 9.4 days. The need for conversion to va-ECMO requires additional expertise that is not readily available despite acute intensive care transport readiness. It is likely that by predicting the need for conversion, early logistical planning for transfer to an appropriate center with experience and equipment can occur, or if transfer is not necessary, staffing and equipment preparation can occur earlier and more safely. As described by Falk et al, planned and prepared conversion can also be expected to have an impact on patient* survival.
The aim of this retrospective, exploratory data analysis is to predict conversion before placement of vv-ECMO within 30 days from ICU care from vv-ECMO to va-ECMO in COVID-19 patients.
- Being tested
- Conversion from vv-ECMO to va-ECMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion from vv-ECMO to va-ECMOProcedure or surgery
Conversion from vv-ECMO to va-ECMO
| Study group | Role | What they receive |
|---|---|---|
| Conversion from vv-ECMO to va-ECMO Positive | Not described Receives: Procedure: Conversion from vv-ECMO to va-ECMO | |
| Conversion from vv-ECMO to va-ECMO Negative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Matrix
Confusion Matrix for Classification of Conversion from vv-ECMO to va-ECMO
Measured: 2019-12-01 to 2023-07-01
Secondary outcomes (1)
Mortality
7, 14, and 30 Day-In Hospital Mortality
Measured: 2019-12-01 to 2023-07-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start30 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to Disease Caused by SARS Co-V-2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910996
- Sponsor's protocol ID
- ECMOPred-vvva
- Acronym
- ECMOPred-vvva
- Status last verified
- Mar 2024
- First submitted
- 15 Jun 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Conversion From Vv-ECMO to Va-ECMO in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05910996
- Acronym / sponsor ID
- ECMOPred-vvva / ECMOPred-vvva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Jun 2023 (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.
In December 2019, cases of a novel lung disease, later referred to as COVID-19, were first reported in China. The virus SARS-CoV-2 was identified as the causative agent. Due to the sharp increase in the number of cases worldwide, a pandemic outbreak was declared by WHO in March 2020.
The infection presents with a broad clinical spectrum. Frequently, there is respiratory infection with fever (80%), dry cough (56%), fatigue (22%), and muscle pain (7%), but completely asymptomatic infection is also possible. Severe courses may be associated with pneumonia resulting in acute respiratory distress syndrome (ARDS) requiring intensive care.
In the context of intensive care therapy, it is sometimes necessary to use extracorporeal organ replacement procedures due to increasing lung failure. In this context, extracorporeal membrane oxygenation (ECMO) was used during the pandemic. With this procedure it is possible to replace on the one hand the oxygenation and ventilation function of the lung and on the other hand additionally the pumping function of the heart, if configured appropriately. The switch from venovenous (vv) configuration, with which only lung function is replaced, to venoarterial (va) configuration (lung function and heart function are replaced) is made in cases of intensive care necessity, e.g., increasing decompensation of heart failure.
Heart failure manifests itself, among other things, through insufficient pumping function of the heart muscle. This results in an undersupply of peripheral tissues with arterial blood, leading to increased anaerobic glycolysis. Lactate and B-type natriuretic peptide (BNP) are used as surrogate parameters of this undersupply. Increased oxygen depletion from oxygen available in arterial blood is detected by the surrogate parameter central venous oxygen saturation (ScvO2).
In addition to ECMO, drug interventions are also used to improve cardiorespiratory performance at various doses. As described by Suwalski et al, there may be a relationship between this drug therapy and conversion from vv to va ECMO.
Currently, few studies exist on conversion from vv-ECMO to va-ECMO. In this regard, Suwalski et al. describe a population that experienced any ECMO therapy for a maximum period of 16.5 ± 10.0 days, with the group with conversion receiving 17.8 ± 10.5 days of therapy and the group without conversion receiving 16.4 ± 9.4 days. The need for conversion to va-ECMO requires additional expertise that is not readily available despite acute intensive care transport readiness. It is likely that by predicting the need for conversion, early logistical planning for transfer to an appropriate center with experience and equipment can occur, or if transfer is not necessary, staffing and equipment preparation can occur earlier and more safely. As described by Falk et al, planned and prepared conversion can also be expected to have an impact on patient* survival.
The aim of this retrospective, exploratory data analysis is to predict conversion before placement of vv-ECMO within 30 days from ICU care from vv-ECMO to va-ECMO in COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversion from vv-ECMO to va-ECMO Positive | – | Procedure: Conversion from vv-ECMO to va-ECMO |
| Conversion from vv-ECMO to va-ECMO Negative | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As described in the inclusion criteria.
Key inclusion criteria (1 listed)
- COVID-19 positive patients aged 18 years or older that were treated in intensive care at the study center between 2019-12-01 and 2023-04-15.
Key exclusion criteria (1 listed)
- Patients in which ECMO therapy was started outside of the study center.
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 |
|---|---|---|
| Conversion from vv-ECMO to va-ECMOConversion from vv-ECMO to va-ECMO | Procedure or surgery | Conversion from vv-ECMO to va-ECMO Positive |
Primary outcome
Confusion Matrix
Time frame: 2019-12-01 to 2023-07-01
Confusion Matrix for Classification of Conversion from vv-ECMO to va-ECMO
1 secondary outcome
Mortality
Time frame: 2019-12-01 to 2023-07-01
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS Due to Disease Caused by SARS Co-V-2, run by Kepler University Hospital at 1 site in Austria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confusion Matrix (time frame: 2019-12-01 to 2023-07-01). 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 6 Mar 2024.