COVID-19 Acute Respiratory Distress SyndromeNCT05780255
Quality of Life 1y and 2 y After VV-ECMO for COVID-19
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication, Quality of Life
- What is being tested?
- VV-ECMO
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Apr 2021to 1 Feb 2024
- 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 PCR-confirmed COVID-19 infection with ARDS who require veno-venous ECMO therapy.
Who may be able to join
- Patients with PCR-confirmed COVID-19 infection AND
- Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life 1y and 2 y After VV-ECMO for COVID-19, Measured by the 36-item Short Form Health Survey
This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.
Read the detailed description
The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health.
The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication, Quality of Life, Death
- Being tested
- VV-ECMO
- Keywords
- ECMO, COVID-19, quality of life
- Medical subject headings
- Death, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV-ECMODevice
veno-venous extracorporeal membrane oxygenation
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive patients | Patients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO Receives: Device: VV-ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
Measured: mortality during hospitalisation, up to two years
Quality of life 1y after ECMO insertion
Result of SF-36 1 year after VV-ECMO insertion
Measured: 1 year
Quality of life 2y after ECMO insertion
Result of SF-36 2 years after VV-ECMO insertion
Measured: 2 years
Secondary outcomes (6)
Lung complications requiring surgical treatment
Hemothorax or lung abcedation
Measured: From the start of VV-ECMO support until weaning of VV-ECMO, up to two years
Duration of mechanical ventilation
Measured: 2 years
LOS ICU
length of stay at the intensive care unit
Measured: from the day of intensive care unit admission until the day of transfer to the ward, up to two years
LOS hospital
length of stay at the hospital
Measured: from the day of hospital admission until the day that the participant is transferred to home, up to two years
death after hospital discharge
all-cause death
Measured: after discharge from the hospital upon 2 years after
Incidence of acute kidney injury
Measured: from the day of hospital admission until the day that the participant is transferred to home, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start20 Apr 2021
- Primary completion31 Jan 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harlinde Peperstraete, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780255
- Sponsor's protocol ID
- COVID-19-ECMO BC-09806
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2023
- Last updated
- 25 Apr 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life 1y and 2 y After VV-ECMO for COVID-19, Measured by the 36-item Short Form Health Survey
- ClinicalTrials.gov ID
- NCT05780255
- Acronym / sponsor ID
- COVID-19-ECMO BC-09806
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication, Quality of Life, Death
- Keywords
- ECMO, COVID-19, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Mar 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.
This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.
Detailed description
The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health.
The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive patients | – | Device: VV-ECMOPatients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PCR-confirmed COVID-19 infection with ARDS who require veno-venous ECMO therapy.
Key inclusion criteria (2 listed)
- Patients with PCR-confirmed COVID-19 infection AND
- Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| VV-ECMOveno-venous extracorporeal membrane oxygenation | Device | COVID-19 positive patients |
Primary outcome
in-hospital mortality
Time frame: mortality during hospitalisation, up to two years
Quality of life 1y after ECMO insertion
Time frame: 1 year
Result of SF-36 1 year after VV-ECMO insertion
Quality of life 2y after ECMO insertion
Time frame: 2 years
Result of SF-36 2 years after VV-ECMO insertion
6 secondary outcomes
Lung complications requiring surgical treatment
Time frame: From the start of VV-ECMO support until weaning of VV-ECMO, up to two years
Duration of mechanical ventilation
Time frame: 2 years
LOS ICU
Time frame: from the day of intensive care unit admission until the day of transfer to the ward, up to two years
LOS hospital
Time frame: from the day of hospital admission until the day that the participant is transferred to home, up to two years
death after hospital discharge
Time frame: after discharge from the hospital upon 2 years after
Incidence of acute kidney injury
Time frame: from the day of hospital admission until the day that the participant is transferred to home, up to two years
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 25 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Acute Respiratory Distress Syndrome
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)
Systemic Inflammatory Response Syndrome
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.
Harlinde Peperstraete principal investigator
UZ Gent
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 COVID-19 Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Ghent at 1 site in Belgium.
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 25 Apr 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 Belgium. 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?
in-hospital mortality (time frame: mortality during hospitalisation, up to two years). The study lists 3 primary outcomes in all. 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 25 Apr 2024.