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
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
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
NCT ID
NCT03352999
First Posted
November 16, 2017
Last Updated
November 22, 2017
Sponsor
Central Hospital, Nancy, France
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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Cardiac Arrest Extra Corporeal Oxygenation Membrane
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