Clinical trial NCT03352999: Cardiac Arrest Extra Corporeal Oxygenation Membrane
Official title: Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Cardiopulmonary Resuscitation
Advanced Cardiac Life Support
Extracorporeal Life Support
Keywords: Refractory out-hospital cardiac arrest
Extracorporeal Life Support
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, monocentric, open, routine care assessment study
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)
timeFrame: 1 year
Secondary outcomes:
measure: Number of survivors with or without neurological sequelae.
timeFrame: at 3 months
measure: Number of survivors with or without neurological sequelae.
timeFrame: at 3 months
measure: Ischemia-reperfusion assessment
timeFrame: from ECMO implantation and day 3
measure: Renal failure
timeFrame: ECMO implantation - Day 1- Day 3
measure: Hepatic failure
timeFrame: ECMO implantation - Day 1 - Day 3
measure: Coagulation Failure
timeFrame: ECMO implantation- Day 1 - Day 3
measure: Respiratory failure
timeFrame: ECMO implantation - Day 1- Day 3
measure: Hemodynamic Failure
timeFrame: from ECMO implantation and day 3
measure: Quality of Resuscitation
timeFrame: from collapse to ECMO implantation (up to 60 minutes)
measure: Pupillary status
timeFrame: at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1
measure: Lactate
timeFrame: Hour 0 - Hour 6 - Hour 12 - Day 1
measure: bispectral index
timeFrame: at arrival in intensive care - Hour 6 - Hour 12 - Day 1
measure: Nosocomial complications
timeFrame: ECMO implantation - Day 1 - Day 3
measure: Nosocomial complications
timeFrame: ECMO implantation - Day 1 - Day 3
measure: Bleeding complications
timeFrame: ECMO implantation - Day 1 - Day 3
measure: Bleeding complications
timeFrame: ECMO implantation - Day 1 - Day 3
Other outcomes:
Locations:
Study officials:
affiliation: CHRU Nancy
name: Antoine Kimmoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.