Cardiac Arrest Extra Corporeal Oxygenation Membrane

Cardiac Arrest Clinical Trial

— CAREECMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03352999
• Other study ID #: 2016-A01873-48.
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 22, 2017
• Start date: December 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2017
• Source: Central Hospital, Nancy, France
• Contact: Antoine Kimmoun, MD
• Phone: 0033383154079
• Email: a.kimmoun[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cardiac Life Support
• Cardiac Arrest
• Cardiopulmonary Resuscitation
• Extracorporeal Life Support
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (1)

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. 20 — View Citation

Outcome

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