Cardiovascular ResuscitationNCT05342363
Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.
An observational study of Cardiovascular Resuscitation and Venovenous Extracorporeal Membrane Oxygenation, run by Goethe University at 1 site in Germany.
Trial summary
In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Resuscitation, Venovenous Extracorporeal Membrane Oxygenation
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2022to 1 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) for respiratory failure in acute respiratory distress syndrome (ARDS). And in addition required mechanical cardiovascular resuscitation treatment during existing therapy with veno-venous extracorporeal membrane oxygenation (vv-ECMO).
Who may be able to join
- Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) due to respiratory failure during acute respiratory distress syndrome (ARDS).
Who cannot join
- Patients treated with veno-arterial extracorporeal membrane oxygenation (va-ECMO)
Trial locations and contacts
1 site in 1 country.
About this study
In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. We are aiming to conduct a retrospective observational study of all vv-ECMO patients treated at our ARDS centre.
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 |
|---|---|---|
| cardiopulmonary resuscitation during treatment with extracorporeal membrane oxygenation | Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) during the retrospective observation period who required mechanical cardiovascular resuscitation (CPR) during their treatment. | |
| Treatment with extracorporeal membrane oxygenation without resuscitation | Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) without the need for cardiovascular resuscitation during the retrospective observation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of mechanical cardiovascular resuscitation
Survival of mechanical cardiovascular resuscitation
Measured: During the intensive care stay ( usually between 2 and 8 weeks)
Secondary outcomes (2)
Incidence of cardiovascular resuscitation i
Incidence of cardiovascular resuscitation in patients treated with venovenous extracorporeal membrane oxygenation.
Measured: During the observation period 2019-2022
Complications of resuscitation treatments
Complications of cardiovascular resuscitation in patients treated with venovenous extracorporeal membrane oxygenation
Measured: During the intensive care stay ( usually between 2 and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jun 2022
- Primary completion1 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ResuscitationStudies 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342363
- Sponsor's protocol ID
- CPR during VV-ECMO
- Status last verified
- Aug 2023
- First submitted
- 16 Apr 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing patient data with third parties is subject to national and local law restrictions and regrettably not possible.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.
- ClinicalTrials.gov ID
- NCT05342363
- Acronym / sponsor ID
- CPR during VV-ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 22 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.
In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. We are aiming to conduct a retrospective observational study of all vv-ECMO patients treated at our ARDS centre.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiopulmonary resuscitation during treatment with extracorporeal membrane oxygenation | – | –Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) during the retrospective observation period who required mechanical cardiovascular resuscitation (CPR) during their treatment. |
| Treatment with extracorporeal membrane oxygenation without resuscitation | – | –Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) without the need for cardiovascular resuscitation during the retrospective observation period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) for respiratory failure in acute respiratory distress syndrome (ARDS). And in addition required mechanical cardiovascular resuscitation treatment during existing therapy with veno-venous extracorporeal membrane oxygenation (vv-ECMO).
Key inclusion criteria (1 listed)
- Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) due to respiratory failure during acute respiratory distress syndrome (ARDS).
Key exclusion criteria (1 listed)
- Patients treated with veno-arterial extracorporeal membrane oxygenation (va-ECMO)
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
Survival of mechanical cardiovascular resuscitation
Time frame: During the intensive care stay ( usually between 2 and 8 weeks)
Survival of mechanical cardiovascular resuscitation
2 secondary outcomes
Incidence of cardiovascular resuscitation i
Time frame: During the observation period 2019-2022
Complications of resuscitation treatments
Time frame: During the intensive care stay ( usually between 2 and 8 weeks)
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 29 Aug 2023.
- Individual participant dataSharing planned: No. Sharing patient data with third parties is subject to national and local law restrictions and regrettably not possible.
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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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 Cardiovascular Resuscitation and Venovenous Extracorporeal Membrane Oxygenation, run by Goethe University at 1 site in Germany.
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 29 Aug 2023. 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 Germany. 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?
Survival of mechanical cardiovascular resuscitation (time frame: During the intensive care stay ( usually between 2 and 8 weeks)). 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 29 Aug 2023.