- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05154071
Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality (ECMO UNIT)
Current evidence suggest that regrouping patient supported by veno-venous ECMO in high-volume centre could improve outcome. A dedicated ECMO unit was implemented in Dijon.
The objective of the present study was to evaluate the implementation of this unit. The hypothesis was that patient taken care within this structured care system would have lower mortality.
This research comprises a retrospective observational study conducted in Dijon university hospital
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- Chu Dijon Bourogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient in an adult Dijon ICUs supported by veno-venous ECMO
- patient hospitalized between January the 1st 2011 and June the 30th 2021
Exclusion Criteria:
- Refusal to participate,
- patient admitted to pediatric ICU
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ECMO VV dedicated unit
Patient having benefited from an ECMO within the structured care unit
|
Collection of adverse events, of mortality, length of hospitalization
|
|
ECMO VV without dedicated unit
Patient having benefited from an ECMO without the structured care unit
|
Collection of adverse events, of mortality, length of hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality rate
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of ECMO adverse events
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Hospital length of stay
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
ICU length of stay
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NGUYEN 2021-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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