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Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) (ECMO-ECMOX2)

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ClinicalTrials.gov Identifier: NCT04548739
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
Istituto Giannina Gaslini
Pediatric Intensive Care Unit, Trousseau University Hospital, France
Pediatric Intensive Care Unit, Necker University Hospital, France
Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:
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.

Condition or disease
Acute Respiratory Distress Syndrome (ARDS) Cardiogenic Shock Cardiac Arrest

Detailed Description:

Patients : All children treated by ECMO in the 4 PICUs involved in the study

Measurements : A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : October 22, 2022
Estimated Study Completion Date : October 22, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Association between CA metrics and neurological outcome [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Analysis of the influence of PCO2 on CA [ Time Frame: 1 year ]
    Association between PCO2 value (mmHg) and COX value

  2. Analysis of the influence of PCO2 on CA [ Time Frame: 1 year ]
    Influence of ECMO settings on CA


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria :

  • Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

  • Lack of parental consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548739


Contacts
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Contact: Nicolas JORAM, MD 02 40 08 76 74 nicolas.joram@chu-nantes.fr
Contact: Annick COULON 02 53 48 28 35 bp-prom-regl@chu-nantes.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, France
Contact: Nicolas Joram         
AP-HP Trousseau Hospital Recruiting
Paris, France, 75012
AP-HP Necker Hospital Recruiting
Paris, France, 75015
Italy
Giannina Gaslini Institute (IRCCS) Not yet recruiting
Genova, Italy, 16148
Sponsors and Collaborators
Nantes University Hospital
Istituto Giannina Gaslini
Pediatric Intensive Care Unit, Trousseau University Hospital, France
Pediatric Intensive Care Unit, Necker University Hospital, France
Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04548739    
Other Study ID Numbers: RC20_0066
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
ECMO
Cerebral autoregulation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Shock, Cardiogenic
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Diseases
 Cardiovascular Diseases
Lung Injury
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Infarction
Ischemia
Pathologic Processes
Necrosis
Shock