COVID-19NCT04340414
Safety and Effectiveness of Low-flow ECMO Driving by CVVH Machine in Severe NCP
A study testing Low flow ECMO driving by CVVH machine in people with COVID-19 and ECMO, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients Read more about this study
- Who is it for?
- Ages 14 years and older
- What is being tested?
- Low flow ECMO driving by CVVH machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2020to 15 Oct 2020
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. NCP with severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<150 and PEEP >10cmH2O
- 2. Driving pressure> 20cmH2O
- 3. RR>30bpm
- 4.PaCO2>55cmH2O and/or PH>7.3
Who cannot join
- 1. poor venous vascular condition and unavaible for central venous catheter placement
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yun Long
Beijing, Beijing Municipality, 100730
Yun Long, +8610169152300, ly_icu@aliyun.com
Xiang Zhou, MD
About this study
Official title: Safety and Effectiveness Study of Low Flow Extracorporeal Membrane Oxygenation（CO2 Removal） Driving by Continuous Hemofiltration Machine the Severe New Corovirus Pneumonia (NCP)
assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients
- Being tested
- Low flow ECMO driving by CVVH machine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow ECMO driving by CVVH machineDevice
With aim to clear CO2 and improve oxygenation, a low flow ECMO treatment(using oxgyenator membrane of kid type ) driving by CVVH machine will be performed in the NCP with severe ARDS
| Study group | Role | What they receive |
|---|---|---|
| NCP patient with severe ARDS and/or high ventilator supported | Experimental | The NCP patient with severe ARDS and/or high ventilator supported condition was eligibilitable for enrollment Receives: Device: Low flow ECMO driving by CVVH machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2
PaCO2 from blood gas analysis
Measured: Day 1
Driving Pressure
Driving Pressure monitor by ventilator
Measured: Day 1
Tidal volume
Tidal volume monitor by ventilator
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start20 Feb 2020
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, Principal investigator, Peking Union Medical College Hospit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340414
- Sponsor's protocol ID
- Low flow-ECMO by CVVH in NCP
- Status last verified
- Jun 2020
- First submitted
- 3 Mar 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding X, Chen H, Zhao H, Zhang H, He H, Cheng W, Wang C, Jiang W, Ma J, Qin Y, Liu Z, Wang J, Yan X, Li T, Zhou X, Long Y, Zhang S. ECCO2R in 12 COVID-19 ARDS Patients With Extremely Low Compliance and Refractory Hypercapnia. Front Med (Lausanne). 2021 Jul 8;8:654658. doi: 10.3389/fmed.2021.654658. eCollection 2021.
PubMed 34307397
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Low Flow Extracorporeal Membrane Oxygenation（CO2 Removal） Driving by Continuous Hemofiltration Machine the Severe New Corovirus Pneumonia (NCP)
- ClinicalTrials.gov ID
- NCT04340414
- Acronym / sponsor ID
- Low flow-ECMO by CVVH in NCP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 9 Apr 2020 (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.
assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCP patient with severe ARDS and/or high ventilator supported | Experimental | Device: Low flow ECMO driving by CVVH machineThe NCP patient with severe ARDS and/or high ventilator supported condition was eligibilitable for enrollment |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 1. NCP with severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<150 and PEEP >10cmH2O
- 2. Driving pressure> 20cmH2O
- 3. RR>30bpm
- 4.PaCO2>55cmH2O and/or PH>7.3
Key exclusion criteria (1 listed)
- 1. poor venous vascular condition and unavaible for central venous catheter placement
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 |
|---|---|---|
| Low flow ECMO driving by CVVH machineWith aim to clear CO2 and improve oxygenation, a low flow ECMO treatment(using oxgyenator membrane of kid type ) driving by CVVH machine will be performed in the NCP with severe ARDS | Device | NCP patient with severe ARDS and/or high ventilator supported |
Primary outcome
PaCO2
Time frame: Day 1
PaCO2 from blood gas analysis
Driving Pressure
Time frame: Day 1
Driving Pressure monitor by ventilator
Tidal volume
Time frame: Day 1
Tidal volume monitor by ventilator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 34307397Ding X, Chen H, Zhao H, Zhang H, He H, Cheng W, Wang C, Jiang W, Ma J, Qin Y, Liu Z, Wang J, Yan X, Li T, Zhou X, Long Y, Zhang S. ECCO2R in 12 COVID-19 ARDS Patients With Extremely Low Compliance and Refractory Hypercapnia. Front Med (Lausanne). 2021 Jul 8;8:654658. doi: 10.3389/fmed.2021.654658. eCollection 2021.
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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.
Yun Long principal investigator
Peking Union Medical College Hospit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flow ECMO driving by CVVH machine in people with COVID-19 and ECMO, run by Peking Union Medical College Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Long, MD (+8610169152300, ly_icu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaCO2 (time frame: Day 1). 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?
On the ClinicalTrials.gov record for NCT04340414, which also lists 1 linked publication.
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 16 Jun 2020.