ARDSNCT05353725
Extracorporeal Membrane Oxygenation in Coronavirus Disease (COVID-19), Influenza and ARDS of Other Ethiologies
An observational study of ARDS and COVID-19, run by University Medical Centre Ljubljana.
Trial summary
A comparison of clinical characteristics and outcomes of patients on extracorporeal membrane oxygenation (ECMO) in COVID-19, influenza and ARDS of other ethiologies Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2022
- 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: Patients with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)
Who may be able to join
- Patient with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)
- 18 years or older
Who cannot join
- Patient not eligible for ECMO treatment per institutional guidelines (terminal illness, palliative care)
About this study
Official title: Extracorporeal Membrane Oxygenation in COVID-19, Influenza and ARDS of Other Ethiologies
A comparison of clinical characteristics and outcomes of patients on extracorporeal membrane oxygenation (ECMO) in COVID-19, influenza and ARDS of other ethiologies
Read the detailed description
All ARDS patients on extracorporeal membrane oxygenation (ECMO) during January 1st 2016 and January 10th 2022 in University Medical Center Ljubljana were included and their clinical characteristics and outcomes were studied according to ARDS ethiology: COVID-19, influenza and other ethiologies.
- Keywords
- Extracorporeal Membrane Oxygenation, ARDS, COVID-19, Influenza
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ARDS | Patients with COVID-19 ARDS on veno-venous ECMO (vvECMO) | |
| Influenza ARDS | Patients with Influenza ARDS on vvECMO | |
| ARDS of Other Ethiologies | Patients with ARDS of Other Ethiologies on vvECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
180-day survival
180-day survival from ECMO implantation
Measured: From day of ECMO-implant for every 24 hours until date of death or survival at 180 days
Secondary outcomes (7)
Days on ECMO
Days on ECMO from ECMO implantation
Measured: From day of ECMO-implant for every 24 hours until date of weaning or death
Weaning from ECMO
Weaning from ECMO
Measured: From day of ECMO-implant until date of death or weaning
ICU length of stay
ICU length of stay from ECMO implantation
Measured: From day of ICU-admission for every 24 hours until date of death or date of ICU discharge
ICU survival
ICU survival from ECMO implantation
Measured: From day of ICU-admission for every 24 hours until date of death or survival at ICU discharge
Hospital survival
Hospital survival from ECMO implantation
Measured: From day of hospital admission for every 24 hours until date of death or survival at hospital discharge
30-day survival
30-day survival from ECMO implantation
Measured: From day of ECMO-implant for every 24 hours until date of death or survival at 30 days
90-day survival
90-day survival from ECMO implantation
Measured: From day of ECMO-implant for every 24 hours until date of death or survival at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jan 2016
- Primary completion10 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jernej Berden, MD, PhD, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353725
- Sponsor's protocol ID
- ECMO in ARDS
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.
PubMed 35123562Chong WH, Saha BK, Medarov BI. A systematic review and meta-analysis comparing the clinical characteristics and outcomes of COVID-19 and influenza patients on ECMO. Respir Investig. 2021 Nov;59(6):748-756. doi: 10.1016/j.resinv.2021.07.006. Epub 2021 Aug 17.
PubMed 34481816Blazoski CM, Baram M, Yang Q, Hirose H. Outcomes of extracorporeal membrane oxygenation in influenza versus COVID-19 during the first wave of COVID-19. J Card Surg. 2021 Oct;36(10):3740-3746. doi: 10.1111/jocs.15888. Epub 2021 Aug 9.
PubMed 34369601
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation in COVID-19, Influenza and ARDS of Other Ethiologies
- ClinicalTrials.gov ID
- NCT05353725
- Acronym / sponsor ID
- ECMO in ARDS
- Keywords
- Extracorporeal Membrane Oxygenation, ARDS, COVID-19, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 29 Apr 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.
A comparison of clinical characteristics and outcomes of patients on extracorporeal membrane oxygenation (ECMO) in COVID-19, influenza and ARDS of other ethiologies
Detailed description
All ARDS patients on extracorporeal membrane oxygenation (ECMO) during January 1st 2016 and January 10th 2022 in University Medical Center Ljubljana were included and their clinical characteristics and outcomes were studied according to ARDS ethiology: COVID-19, influenza and other ethiologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ARDS | – | –Patients with COVID-19 ARDS on veno-venous ECMO (vvECMO) |
| Influenza ARDS | – | –Patients with Influenza ARDS on vvECMO |
| ARDS of Other Ethiologies | – | –Patients with ARDS of Other Ethiologies on vvECMO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)
Key inclusion criteria (2 listed)
- Patient with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)
- 18 years or older
Key exclusion criteria (1 listed)
- Patient not eligible for ECMO treatment per institutional guidelines (terminal illness, palliative care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
180-day survival
Time frame: From day of ECMO-implant for every 24 hours until date of death or survival at 180 days
180-day survival from ECMO implantation
7 secondary outcomes
Days on ECMO
Time frame: From day of ECMO-implant for every 24 hours until date of weaning or death
Weaning from ECMO
Time frame: From day of ECMO-implant until date of death or weaning
ICU length of stay
Time frame: From day of ICU-admission for every 24 hours until date of death or date of ICU discharge
ICU survival
Time frame: From day of ICU-admission for every 24 hours until date of death or survival at ICU discharge
Hospital survival
Time frame: From day of hospital admission for every 24 hours until date of death or survival at hospital discharge
30-day survival
Time frame: From day of ECMO-implant for every 24 hours until date of death or survival at 30 days
90-day survival
Time frame: From day of ECMO-implant for every 24 hours until date of death or survival at 90 days
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 5 May 2022.
- Background: PubMed 35123562Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.
- Background: PubMed 34481816Chong WH, Saha BK, Medarov BI. A systematic review and meta-analysis comparing the clinical characteristics and outcomes of COVID-19 and influenza patients on ECMO. Respir Investig. 2021 Nov;59(6):748-756. doi: 10.1016/j.resinv.2021.07.006. Epub 2021 Aug 17.
- Background: PubMed 34369601Blazoski CM, Baram M, Yang Q, Hirose H. Outcomes of extracorporeal membrane oxygenation in influenza versus COVID-19 during the first wave of COVID-19. J Card Surg. 2021 Oct;36(10):3740-3746. doi: 10.1111/jocs.15888. Epub 2021 Aug 9.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and COVID-19, run by University Medical Centre Ljubljana.
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 2 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
180-day survival (time frame: From day of ECMO-implant for every 24 hours until date of death or survival at 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353725, which also lists 3 linked publications.
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 5 May 2022.