COVID-19NCT05158816
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
An observational study of COVID-19, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Retrospective single center analyses of COVID-19 patients admitted to the ICU between 01/02/2020 and 31/07/2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 295 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Sep 2021to 30 Nov 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: All adult COVID-19 patients (>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage
Who may be able to join
- All adult COVID-19 patients (>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage
Who cannot join
- All adult patients admitted for other reasons to the ICU (no COVID-19 pneumonia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19: a Single Centre Analysis
Retrospective single center analyses of COVID-19 patients admitted to the ICU between 01/02/2020 and 31/07/2021.
Read the detailed description
All adults (>18 years) with acute hypoxaemic respiratory failure due to diagnosed COVID-19 pneumonia and admitted to ICU from 01/02/2020 until 31/07/2021 were included in the study. Following the World Health Organisation (WHO) protocol 19, laboratory confirmation of COVID-19 infection was defined as a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage. Only laboratory-confirmed patients were included in the analysis.
Additional data collection
Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:
- Demographics: i.e age, gender, BMI
- DNR code
- Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other
- Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
- Laboratory results of all standard parameters measured
- Treatment: antiviral agents, antibiotics, etc…
- Complications: shock, heart failure, sepsis, stroke, etc…
- Ventilation: method, PEEP, FiO2, P/F ratio ..
- Conditions
- COVID-19
- Being tested
- ECMO
- Keywords
- ECMO
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMOProcedure or surgery
Patients undergoing extracorporeal membrane oxygenation
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | COVID-19 patients admitted to the ICU Receives: Procedure: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
mortality of patients during their stay at the ICU
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
3 Months Mortality
Mortality of patients
Measured: 3 months after admission to ICU
acute kidney injury
incidence of acute kidney injury
Measured: through study completion, an average of 1 year
continous renal replacement therapy
incidence of continous renal replacement therapy
Measured: through study completion, an average of 1 year
Length of stay in hospital
Length of stay in hospital
Measured: through study completion, an average of 1 year
Length of stay in ICU
Length of stay in ICU
Measured: during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start8 Sep 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158816
- Sponsor's protocol ID
- f/2021/097
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madrid-Valero JJ, Ware J, Allen JM, Boughton CK, Hartnell S, Wilinska ME, Thankamony A, de Beaufort C, Schierloh U, Campbell FM, Sibayan J, Bocchino LE, Kollman C, Hovorka R, Gregory AM, Consortium K. Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-Augmented Pump. Pediatr Diabetes. 2023 Jun 13;2023:7937007. doi: 10.1155/2023/7937007. eCollection 2023.
PubMed 40303271Stessel B, Bin Saad M, Ullrick L, Geebelen L, Lehaen J, Timmermans PJ, Van Tornout M, Callebaut I, Vandenbrande J, Dubois J. Extracorporeal Membrane Oxygenation to Support COVID-19 Patients: A Propensity-Matched Cohort Study. Crit Care Res Pract. 2023 Jun 12;2023:5101456. doi: 10.1155/2023/5101456. eCollection 2023.
PubMed 37342313
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19: a Single Centre Analysis
- ClinicalTrials.gov ID
- NCT05158816
- Acronym / sponsor ID
- f/2021/097
- Conditions
- COVID-19
- Keywords
- ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Dec 2021 (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.
Retrospective single center analyses of COVID-19 patients admitted to the ICU between 01/02/2020 and 31/07/2021.
Detailed description
All adults (>18 years) with acute hypoxaemic respiratory failure due to diagnosed COVID-19 pneumonia and admitted to ICU from 01/02/2020 until 31/07/2021 were included in the study. Following the World Health Organisation (WHO) protocol 19, laboratory confirmation of COVID-19 infection was defined as a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage. Only laboratory-confirmed patients were included in the analysis.
Additional data collection
Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:
- Demographics: i.e age, gender, BMI
- DNR code
- Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other
- Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
- Laboratory results of all standard parameters measured
- Treatment: antiviral agents, antibiotics, etc…
- Complications: shock, heart failure, sepsis, stroke, etc…
- Ventilation: method, PEEP, FiO2, P/F ratio ..
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Procedure: ECMOCOVID-19 patients admitted to the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult COVID-19 patients (>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage
Key inclusion criteria (1 listed)
- All adult COVID-19 patients (>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage
Key exclusion criteria (1 listed)
- All adult patients admitted for other reasons to the ICU (no COVID-19 pneumonia)
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 |
|---|---|---|
| ECMOPatients undergoing extracorporeal membrane oxygenation | Procedure or surgery | COVID-19 patients |
Primary outcome
Mortality
Time frame: through study completion, an average of 1 year
mortality of patients during their stay at the ICU
5 secondary outcomes
3 Months Mortality
Time frame: 3 months after admission to ICU
acute kidney injury
Time frame: through study completion, an average of 1 year
continous renal replacement therapy
Time frame: through study completion, an average of 1 year
Length of stay in hospital
Time frame: through study completion, an average of 1 year
Length of stay in ICU
Time frame: during ICU stay
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 21 Dec 2022.
- Derived from this study: PubMed 40303271Madrid-Valero JJ, Ware J, Allen JM, Boughton CK, Hartnell S, Wilinska ME, Thankamony A, de Beaufort C, Schierloh U, Campbell FM, Sibayan J, Bocchino LE, Kollman C, Hovorka R, Gregory AM, Consortium K. Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-Augmented Pump. Pediatr Diabetes. 2023 Jun 13;2023:7937007. doi: 10.1155/2023/7937007. eCollection 2023.
- Derived from this study: PubMed 37342313Stessel B, Bin Saad M, Ullrick L, Geebelen L, Lehaen J, Timmermans PJ, Van Tornout M, Callebaut I, Vandenbrande J, Dubois J. Extracorporeal Membrane Oxygenation to Support COVID-19 Patients: A Propensity-Matched Cohort Study. Crit Care Res Pract. 2023 Jun 12;2023:5101456. doi: 10.1155/2023/5101456. eCollection 2023.
- 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 COVID-19, run by Jessa Hospital 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 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 21 Dec 2022. 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?
Mortality (time frame: through study completion, an average of 1 year). 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 NCT05158816, which also lists 2 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 21 Dec 2022.