Cardiac Arrest Extra Corporeal Oxygenation Membrane (CAREECMO)

Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Arrest; Cardiopulmonary Resuscitation; Extracorporeal Life Support; Advanced Cardiac Life Support
• Intervention / Treatment: Procedure: Fast track access to vaECMO

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine Kimmoun, MD; Phone Number: 0033383154079; Email: a.kimmoun@chru-nancy.fr
• Study Contact Backup: Name: Tahar Chouied, MD; Email: t.chouied@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of survivors with or without neurological sequelae.	Number of survivors with or without neurological sequelae (DRS from 0 to 29)	at 3 months
Number of survivors with or without neurological sequelae.	European quality of life scale EQ-5D at 3 months	at 3 months
Ischemia-reperfusion assessment	Amount of fluid infused	from ECMO implantation and day 3
Renal failure	Worst KDIGO stage	ECMO implantation - Day 1- Day 3
Hepatic failure	Worst values of PT/bilirubin/ AST and ALT	ECMO implantation - Day 1 - Day 3
Coagulation Failure	platelets/PT/Fibrinogen	ECMO implantation- Day 1 - Day 3
Respiratory failure	PaO2/iFO2 value	ECMO implantation - Day 1- Day 3
Hemodynamic Failure	Amount of Norepinephrine infused	from ECMO implantation and day 3
Quality of Resuscitation	Total duration of the resuscitation: from collapse to ECMO implantation	from collapse to ECMO implantation (up to 60 minutes)
Pupillary status	Pupillary status	at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1
Lactate	amount of Lactate	Hour 0 - Hour 6 - Hour 12 - Day 1
bispectral index	bispectral index	at arrival in intensive care - Hour 6 - Hour 12 - Day 1
Nosocomial complications	Infection of the canulation site	ECMO implantation - Day 1 - Day 3
Nosocomial complications	bacteraemia	ECMO implantation - Day 1 - Day 3
Bleeding complications	blood hemostasis disorder	ECMO implantation - Day 1 - Day 3
Bleeding complications	bleeding	ECMO implantation - Day 1 - Day 3

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Antoine Kimmoun, MD, CHRU Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Extracorporeal Life Support; Refractory out-hospital cardiac arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2016-A01873-48.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No