Cardiac ArrestCAREECMONCT03352999
Cardiac Arrest Extra Corporeal Oxygenation Membrane
A study testing Fast track access to vaECMO in people with Cardiac Arrest and Cardiopulmonary Resuscitation, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Resuscitation, Advanced Cardiac Life Support
- What is being tested?
- Fast track access to vaECMO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Apparent obvious comorbidities
- Patient < 18 yo
- Pregnancy
- Patient under protective supervision
Trial locations and contacts
No sites are listed yet.
Tahar Chouied, MD contact
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation, Advanced Cardiac Life Support, Extracorporeal Life Support
- Being tested
- Fast track access to vaECMO
- Keywords
- Refractory out-hospital cardiac arrest, Extracorporeal Life Support
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast track access to vaECMOProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ROHCA rescued by vaECMO | Other | Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device. Receives: Procedure: Fast track access to vaECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (16)
Number of survivors with or without neurological sequelae.
Number of survivors with or without neurological sequelae (DRS from 0 to 29)
Measured: at 3 months
Number of survivors with or without neurological sequelae.
European quality of life scale EQ-5D at 3 months
Measured: at 3 months
Ischemia-reperfusion assessment
Amount of fluid infused
Measured: from ECMO implantation and day 3
Renal failure
Worst KDIGO stage
Measured: ECMO implantation - Day 1- Day 3
Hepatic failure
Worst values of PT/bilirubin/ AST and ALT
Measured: ECMO implantation - Day 1 - Day 3
Coagulation Failure
platelets/PT/Fibrinogen
Measured: ECMO implantation- Day 1 - Day 3
Respiratory failure
PaO2/iFO2 value
Measured: ECMO implantation - Day 1- Day 3
Hemodynamic Failure
Amount of Norepinephrine infused
Measured: from ECMO implantation and day 3
Quality of Resuscitation
Total duration of the resuscitation: from collapse to ECMO implantation
Measured: from collapse to ECMO implantation (up to 60 minutes)
Pupillary status
Pupillary status
Measured: at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1
Lactate
amount of Lactate
Measured: Hour 0 - Hour 6 - Hour 12 - Day 1
bispectral index
bispectral index
Measured: at arrival in intensive care - Hour 6 - Hour 12 - Day 1
Nosocomial complications
Infection of the canulation site
Measured: ECMO implantation - Day 1 - Day 3
Nosocomial complications
bacteraemia
Measured: ECMO implantation - Day 1 - Day 3
Bleeding complications
blood hemostasis disorder
Measured: ECMO implantation - Day 1 - Day 3
Bleeding complications
bleeding
Measured: ECMO implantation - Day 1 - Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, monocentric, open, routine care assessment study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Kimmoun, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352999
- Sponsor's protocol ID
- 2016-A01873-48.
- Acronym
- CAREECMO
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28682938
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry
- ClinicalTrials.gov ID
- NCT03352999
- Acronym / sponsor ID
- CAREECMO / 2016-A01873-48.
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation, Advanced Cardiac Life Support, Extracorporeal Life Support
- Keywords
- Refractory out-hospital cardiac arrest, Extracorporeal Life Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, monocentric, open, routine care assessment study
| Arm | Type | Receives |
|---|---|---|
| ROHCA rescued by vaECMO | Other | Procedure: Fast track access to vaECMOPatients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Apparent obvious comorbidities
- Patient < 18 yo
- Pregnancy
- Patient under protective supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast track access to vaECMOROHCA 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. | Procedure or surgery | ROHCA rescued by vaECMO |
Primary outcome
Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)
Time frame: 1 year
Number of survivors without neurological sequelae (DRS scale from 0 to 6)
16 secondary outcomes
Number of survivors with or without neurological sequelae.
Time frame: at 3 months
Number of survivors with or without neurological sequelae.
Time frame: at 3 months
Ischemia-reperfusion assessment
Time frame: from ECMO implantation and day 3
Renal failure
Time frame: ECMO implantation - Day 1- Day 3
Hepatic failure
Time frame: ECMO implantation - Day 1 - Day 3
Coagulation Failure
Time frame: ECMO implantation- Day 1 - Day 3
Respiratory failure
Time frame: ECMO implantation - Day 1- Day 3
Hemodynamic Failure
Time frame: from ECMO implantation and day 3
Quality of Resuscitation
Time frame: from collapse to ECMO implantation (up to 60 minutes)
Pupillary status
Time frame: at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1
Lactate
Time frame: Hour 0 - Hour 6 - Hour 12 - Day 1
bispectral index
Time frame: at arrival in intensive care - Hour 6 - Hour 12 - Day 1
Nosocomial complications
Time frame: ECMO implantation - Day 1 - Day 3
Nosocomial complications
Time frame: ECMO implantation - Day 1 - Day 3
Bleeding complications
Time frame: ECMO implantation - Day 1 - Day 3
Bleeding complications
Time frame: ECMO implantation - Day 1 - Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Results publication: PubMed 28682938Chouihed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tahar Chouied, MD contact
Antoine Kimmoun, MD principal investigator
CHRU Nancy
Questions about this trial
What is this clinical trial studying?
A study testing Fast track access to vaECMO in people with Cardiac Arrest and Cardiopulmonary Resuscitation, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Kimmoun, MD (0033383154079, a.kimmoun@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.