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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03352999
Other study ID # 2016-A01873-48.
Secondary ID
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
Health authority
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

Study Design


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
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