ExtraCorporeal Membrane OxygenationECMONOMYNCT03686540
Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center
An observational study of ExtraCorporeal Membrane Oxygenation, run by Rennes University Hospital at 1 site in France.
Trial summary
The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ExtraCorporeal Membrane Oxygenation
- What is being tested?
- ExtraCorporeal Membrane Oxygenation (ECMO)
- Type of treatment
- Surgery or procedure
- How many people
- 620 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 13 Dec 2017
- 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 who benefited from an ECMO at Rennes University Hospital Center
Who may be able to join
- All patients ≥18 years old who have benefited from an ECMO (no type, no indication) between 2004 and 2016 at the Rennes University Hospital, identified in the database of the Rennes University Hospital Center will be included in this study.
Who cannot join
- Neither
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.
- Conditions
- ExtraCorporeal Membrane Oxygenation
- Being tested
- ExtraCorporeal Membrane Oxygenation (ECMO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtraCorporeal Membrane Oxygenation (ECMO)Procedure or surgery
The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.
What is being measured
The primary outcome is the main question the study is designed to answer.
Average net costs
Average net costs (total and by expense) for the hospital facility (Rennes University Hospital) of the initial hospitalization. The average net cost for the institution is defined as the average difference between the production costs for the hospital and the incomes donated to the institution by the Health Insurance.
Measured: 1 day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start13 Dec 2017
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtraCorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Rennes University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686540
- Sponsor's protocol ID
- 35RC17_3042_ECMONOMY
- Acronym
- ECMONOMY
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center
- ClinicalTrials.gov ID
- NCT03686540
- Acronym / sponsor ID
- ECMONOMY / 35RC17_3042_ECMONOMY
- Conditions
- ExtraCorporeal Membrane Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 27 Sep 2018 (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.
The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who benefited from an ECMO at Rennes University Hospital Center
Key inclusion criteria (1 listed)
- All patients ≥18 years old who have benefited from an ECMO (no type, no indication) between 2004 and 2016 at the Rennes University Hospital, identified in the database of the Rennes University Hospital Center will be included in this study.
Key exclusion criteria (1 listed)
- Neither
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 |
|---|---|---|
| ExtraCorporeal Membrane Oxygenation (ECMO)The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted. | Procedure or surgery | – |
Primary outcome
Average net costs
Time frame: 1 day of inclusion
Average net costs (total and by expense) for the hospital facility (Rennes University Hospital) of the initial hospitalization. The average net cost for the institution is defined as the average difference between the production costs for the hospital and the incomes donated to the institution by the Health Insurance.
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 27 Sep 2018.
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Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
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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 ExtraCorporeal Membrane Oxygenation, run by Rennes University Hospital at 1 site in France.
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 27 Sep 2018. 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 France. 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?
Average net costs (time frame: 1 day of inclusion). 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 27 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.