Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Arrest Extra Corporeal Oxygenation Membrane (CAREECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03352999
Recruitment Status : Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Cardiopulmonary Resuscitation Advanced Cardiac Life Support Extracorporeal Life Support Procedure: Fast track access to vaECMO Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, monocentric, open, routine care assessment study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
ROHCA rescued by vaECMO
Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device.
 Procedure: Fast track access to vaECMO

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6) [ Time Frame: 1 year ]
    Number of survivors without neurological sequelae (DRS scale from 0 to 6)


Secondary Outcome Measures :
  1. Number of survivors with or without neurological sequelae. [ Time Frame: at 3 months ]
    Number of survivors with or without neurological sequelae (DRS from 0 to 29)

  2. Number of survivors with or without neurological sequelae. [ Time Frame: at 3 months ]
    European quality of life scale EQ-5D at 3 months

  3. Ischemia-reperfusion assessment [ Time Frame: from ECMO implantation and day 3 ]
    Amount of fluid infused

  4. Renal failure [ Time Frame: ECMO implantation - Day 1- Day 3 ]
    Worst KDIGO stage

  5. Hepatic failure [ Time Frame: ECMO implantation - Day 1 - Day 3 ]
    Worst values of PT/bilirubin/ AST and ALT

  6. Coagulation Failure [ Time Frame: ECMO implantation- Day 1 - Day 3 ]
    platelets/PT/Fibrinogen

  7. Respiratory failure [ Time Frame: ECMO implantation - Day 1- Day 3 ]
    PaO2/iFO2 value

  8. Hemodynamic Failure [ Time Frame: from ECMO implantation and day 3 ]
    Amount of Norepinephrine infused

  9. Quality of Resuscitation [ Time Frame: from collapse to ECMO implantation (up to 60 minutes) ]
    Total duration of the resuscitation: from collapse to ECMO implantation

  10. Pupillary status [ Time Frame: at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1 ]
    Pupillary status

  11. Lactate [ Time Frame: Hour 0 - Hour 6 - Hour 12 - Day 1 ]
    amount of Lactate

  12. bispectral index [ Time Frame: at arrival in intensive care - Hour 6 - Hour 12 - Day 1 ]
    bispectral index

  13. Nosocomial complications [ Time Frame: ECMO implantation - Day 1 - Day 3 ]
    Infection of the canulation site

  14. Nosocomial complications [ Time Frame: ECMO implantation - Day 1 - Day 3 ]
    bacteraemia

  15. Bleeding complications [ Time Frame: ECMO implantation - Day 1 - Day 3 ]
    blood hemostasis disorder

  16. Bleeding complications [ Time Frame: ECMO implantation - Day 1 - Day 3 ]
    bleeding


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03352999


Contacts
Layout table for location contacts
Contact: Antoine Kimmoun, MD 0033383154079 a.kimmoun@chru-nancy.fr
Contact: Tahar Chouied, MD t.chouied@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Principal Investigator: Antoine Kimmoun, MD CHRU Nancy
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03352999    
Other Study ID Numbers: 2016-A01873-48.
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Refractory out-hospital cardiac arrest
Extracorporeal Life Support
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Heart Diseases
Cardiovascular Diseases