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Cardiac Arrest Extra Corporeal Oxygenation Membrane (CAREECMO)

Primary Purpose

Cardiac Arrest, Cardiopulmonary Resuscitation, Advanced Cardiac Life Support

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fast track access to vaECMO
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest focused on measuring Refractory out-hospital cardiac arrest, Extracorporeal Life Support

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Witnessed out-of-hospital cardiac arrest
  • in qualified geographical locations
  • No Return of spontaneous circulation (ROSC) after 10 min of CPR
  • No Flow <1 min

Exclusion Criteria:

  • Apparent obvious comorbidities
  • Patient < 18 yo
  • Pregnancy
  • Patient under protective supervision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    ROHCA rescued by vaECMO

    Arm Description

    Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device.

    Outcomes

    Primary Outcome Measures

    Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)
    Number of survivors without neurological sequelae (DRS scale from 0 to 6)

    Secondary Outcome Measures

    Number of survivors with or without neurological sequelae.
    Number of survivors with or without neurological sequelae (DRS from 0 to 29)
    Number of survivors with or without neurological sequelae.
    European quality of life scale EQ-5D at 3 months
    Ischemia-reperfusion assessment
    Amount of fluid infused
    Renal failure
    Worst KDIGO stage
    Hepatic failure
    Worst values of PT/bilirubin/ AST and ALT
    Coagulation Failure
    platelets/PT/Fibrinogen
    Respiratory failure
    PaO2/iFO2 value
    Hemodynamic Failure
    Amount of Norepinephrine infused
    Quality of Resuscitation
    Total duration of the resuscitation: from collapse to ECMO implantation
    Pupillary status
    Pupillary status
    Lactate
    amount of Lactate
    bispectral index
    bispectral index
    Nosocomial complications
    Infection of the canulation site
    Nosocomial complications
    bacteraemia
    Bleeding complications
    blood hemostasis disorder
    Bleeding complications
    bleeding

    Full Information

    First Posted
    November 16, 2017
    Last Updated
    November 22, 2017
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03352999
    Brief Title
    Cardiac Arrest Extra Corporeal Oxygenation Membrane
    Acronym
    CAREECMO
    Official Title
    Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2017 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    French guidelines for Cardio Pulmonary Resuscitation (CPR) consider Extra-Corporeal Life Support (ECLS) as one option in Refractory out-of hospital Cardiac Arrest (ROHCA) patients with a no-flow less than five minutes and absence of spontaneous circulation 30 minutes after initiation of advanced CPR. Duration of both pre-CPR arrest (no-flow) and of CPR (low-flow) have been systematically highlighted as crucial prognostic factors in all observational studies focused on ROHCA. In order to shorten the time to ECLS initiation, the most recent European Resuscitation Council guidelines recommend, in eligible ROHCA patients, a fast track access to ECLS implantation. CHRU Nancy elaborated an operational strategy which was designed to improve the enrolment of eligible ROHCA patients and to reduce the delay time between recognition and ECLS initiation. The objective of the present register was to assess prospectively the impact of this new operational strategy over a 5 years period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Cardiopulmonary Resuscitation, Advanced Cardiac Life Support, Extracorporeal Life Support
    Keywords
    Refractory out-hospital cardiac arrest, Extracorporeal Life Support

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, monocentric, open, routine care assessment study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ROHCA rescued by vaECMO
    Arm Type
    Other
    Arm Description
    Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device.
    Intervention Type
    Procedure
    Intervention Name(s)
    Fast track access to vaECMO
    Intervention Description
    ROHCA must be witnessed with onset of bystander CPR and an immediate call to Emergency Dispatch. Furthermore, to minimize any loss of time, all qualified geographical locations are directly incorporated in the regulation software of the center for medical emergency control. Patients suitable for vaECMO implantation were identified as early as possible by the Medical Dispatcher at the Emergency Call Dispatch Center. Bystanders pursued CPR until Mobile Intensive Care Unit (MICU) arrival. OHCA was considered refractory after 10 min of CPR initiating the transport by MICU to the hospital such that the vaECMO intervention could be performed. The resuscitation was pursued during the transfer to hospital. An automated chest compression device was used in order to minimize interruption periods. The intensivists and cardiac surgeons stood ready to implant the vaECMO surgically in the catheterization laboratory where a percutaneous coronary intervention was subsequently performed.
    Primary Outcome Measure Information:
    Title
    Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)
    Description
    Number of survivors without neurological sequelae (DRS scale from 0 to 6)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Number of survivors with or without neurological sequelae.
    Description
    Number of survivors with or without neurological sequelae (DRS from 0 to 29)
    Time Frame
    at 3 months
    Title
    Number of survivors with or without neurological sequelae.
    Description
    European quality of life scale EQ-5D at 3 months
    Time Frame
    at 3 months
    Title
    Ischemia-reperfusion assessment
    Description
    Amount of fluid infused
    Time Frame
    from ECMO implantation and day 3
    Title
    Renal failure
    Description
    Worst KDIGO stage
    Time Frame
    ECMO implantation - Day 1- Day 3
    Title
    Hepatic failure
    Description
    Worst values of PT/bilirubin/ AST and ALT
    Time Frame
    ECMO implantation - Day 1 - Day 3
    Title
    Coagulation Failure
    Description
    platelets/PT/Fibrinogen
    Time Frame
    ECMO implantation- Day 1 - Day 3
    Title
    Respiratory failure
    Description
    PaO2/iFO2 value
    Time Frame
    ECMO implantation - Day 1- Day 3
    Title
    Hemodynamic Failure
    Description
    Amount of Norepinephrine infused
    Time Frame
    from ECMO implantation and day 3
    Title
    Quality of Resuscitation
    Description
    Total duration of the resuscitation: from collapse to ECMO implantation
    Time Frame
    from collapse to ECMO implantation (up to 60 minutes)
    Title
    Pupillary status
    Description
    Pupillary status
    Time Frame
    at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1
    Title
    Lactate
    Description
    amount of Lactate
    Time Frame
    Hour 0 - Hour 6 - Hour 12 - Day 1
    Title
    bispectral index
    Description
    bispectral index
    Time Frame
    at arrival in intensive care - Hour 6 - Hour 12 - Day 1
    Title
    Nosocomial complications
    Description
    Infection of the canulation site
    Time Frame
    ECMO implantation - Day 1 - Day 3
    Title
    Nosocomial complications
    Description
    bacteraemia
    Time Frame
    ECMO implantation - Day 1 - Day 3
    Title
    Bleeding complications
    Description
    blood hemostasis disorder
    Time Frame
    ECMO implantation - Day 1 - Day 3
    Title
    Bleeding complications
    Description
    bleeding
    Time Frame
    ECMO implantation - Day 1 - Day 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Witnessed out-of-hospital cardiac arrest in qualified geographical locations No Return of spontaneous circulation (ROSC) after 10 min of CPR No Flow <1 min Exclusion Criteria: Apparent obvious comorbidities Patient < 18 yo Pregnancy Patient under protective supervision
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antoine Kimmoun, MD
    Phone
    0033383154079
    Email
    a.kimmoun@chru-nancy.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tahar Chouied, MD
    Email
    t.chouied@chru-nancy.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antoine Kimmoun, MD
    Organizational Affiliation
    CHRU Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28682938
    Citation
    Chouihed T, Kimmoun A, Lauvray A, Laithier FX, Jaeger D, Lemoine S, Maureira JP, Nace L, Duarte K, Albizzati S, Girerd N, Levy B. Improving Patient Selection for Refractory Out of Hospital Cardiac Arrest Treated with Extracorporeal Life Support. Shock. 2018 Jan;49(1):24-28. doi: 10.1097/SHK.0000000000000941.
    Results Reference
    result

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