NCT04548739|Completed
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
ECMO-ECMOX2
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ECMO-ECMOX2
Sponsor study identifier
observational
132
2 countries
4
Study Start
October 22, 2020
Actual (reported)Primary Completion
October 16, 2023
Actual (reported)Study Completion
October 16, 2023
Actual (reported)Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 16, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2020
Actual (reported)September 14, 2020
Actual (reported)October 22, 2020
Actual (reported)October 16, 2023
Actual (reported)October 16, 2023
Actual (reported)Association between CA metrics and neurological outcome
Association between the percentage of time spent in critical region of CA and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not.
1 year
Analysis of the influence of PCO2 on CA
1 year
Analysis of the influence of PCO2 on CA
1 year
100 children admitted to the Pediatric Intensive Care Unit (PICU) of Nantes (France), Trousseau (Paris, France), Necker (Paris, France) or Genoa (Italy) and supported by ECMO for hemodynamic or respiratory indication or during cardiac arrest resuscitation will be included in the study. As ECMO is an emergency procedure, emergency inclusions may be needed. Other observational study may be conducted in parallel in this population.
CHU de Nantes
Nantes, France
AP-HP Trousseau Hospital
Paris, 75012, France
AP-HP Necker Hospital
Paris, 75015, France
Giannina Gaslini Institute (IRCCS)
Genova, 16148, Italy
Nicolas JORAM, MD
Nantes University Hospital
132 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2020
First Posted
September 14, 2020
Study Start
October 22, 2020
Actual (reported)Assessment of Cardiac Output in Patients With ARDS Implanted With Venous-venous ECMO.
Contact the study team to confirm eligibility.
Primary Completion
October 16, 2023
Actual (reported)Study Completion
October 16, 2023
Actual (reported)Last Updated
January 11, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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