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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Austria1 site
  • Kepler University Hospital

    Linz, Upper Austria, 4020

Other trials in Austria

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 groups in NCT05910996
Study groupRoleWhat they receive
Conversion from vv-ECMO to va-ECMO PositiveNot described
Receives: Procedure: Conversion from vv-ECMO to va-ECMO
Conversion from vv-ECMO to va-ECMO NegativeNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted20 Jun 2023
  2. Study start30 Sep 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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)
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

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.

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