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Trial record 1 of 1 for:    NCT03101787
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Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)

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ClinicalTrials.gov Identifier: NCT03101787
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : October 18, 2022
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Getinge Group
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Out-Of-Hospital Cardiac Arrest Sudden Cardiac Death Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR) Not Applicable

Detailed Description:

There are approximately 275,000 cases of out-of-hospital cardiac arrest (OHCA) per year in Europe, of which two-thirds have a primary cardiac origin. However, despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of these patients fail to achieve sustained return of spontaneous circulation (ROSC).

Treatment of the underlying cause of the arrest, in most cases coronary artery occlusion, is paramount. But in the absence of ROSC, the possibilities to perform these life-saving interventions are limited. Continued CCPR is currently the standard of care for these patients. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR) restores circulation, with the potential to minimize (or even reversing) organ damage, prevent re-arrest due to ischemia-triggered myocardial dysfunction and providing a bridge to possible diagnosis and treatment. Several studies have demonstrated that ECPR is feasible and may be advantageous with respect to survival and neurological outcome.

The INCEPTION trial aims to compare ECPR to CCPR in the population that is expected to benefit the most from this intervention: young patients presenting with ventricular fibrillation or tachycardia (VF/VT) and a refractory cardiac arrest. Furthermore, it will provide data on the cost-effectiveness of this intervention, which to date has been unavailable. Although the costs may prove to be high, the gain in quality-adjusted life years (QALY's) may be substantial given the fact that most patients are relatively young and the current alternative carries a poor prognosis. This can determine whether ECPR should be pursued as a standard of care in patients with refractory arrest.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: CCPR protocol

Preclinical Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and rapid transport to the emergency department with ongoing mechanical CPR and advanced cardiac life support (ACLS).

Clinical Upon the patient's arrival, the standard of care (CCPR) will be continued according to ERC guidelines.

No special preparations for the trial are needed before the patient's arrival.

Experimental: ECPR protocol

Preclinical Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and transport to the emergency department with ongoing mechanical CPR and advanced cardiac life support (ACLS).

Clinical The ECPR team is mobilized while the patient is transported to the hospital. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR).

Time from arrest to start of cannulation is < 60 minutes.

Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)

In addition to the routine response team, the ECLS team are called to the ED while the patient is transported to the hospital.

The team consists of a physician skilled and qualified in femoral cannulation, a perfusionist and a scrub nurse.

Upon the patient's arrival at the emergency department, CPR will be continued, with continuation of mechanical chest compressions with minimization of interruptions.

Time from arrest to start of cannulation is < 60 minutes.





Primary Outcome Measures :
  1. 30-day survival rate with favorable neurological status [ Time Frame: 30 days ]
    Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale


Secondary Outcome Measures :
  1. Neurological outcome on the CPC scale [ Time Frame: 30 days, 3 months, 6 months and 12 months ]
    Does ECPR improve the neurological outcome at 30 days, 3 months, 6 months and 12 months on the CPC scale

  2. Quality Adjusted Life Years (QALY's) [ Time Frame: 30 days, 3 months, 6 months and 12 months ]
    Does ECPR improve the amount of Quality Adjusted Life Years (QALY's) at 30 days, 3 months, 6 months and 12 months

  3. Reason for discontinuation of treatment between the treatment groups [ Time Frame: Within 1 year ]
    Is there a difference in reason for discontinuation of treatment between the treatment groups

  4. Time to return of circulation [ Time Frame: Within 1 year ]
    What is the time to return of circulation

  5. Additional costs of ECPR with respect to CCPR [ Time Frame: 1 year ]
    What are the additional costs of ECPR with respect to CCPR

  6. Costs per gained QALY for ECPR vs. CCPR [ Time Frame: 1 year ]
    What are the costs per gained QALY for ECPR vs. CCPR

  7. Length of stay at the ICU [ Time Frame: 1 year ]
    Is there a difference in length of stay at the ICU between the treatment groups

  8. Length of stay at the hospital [ Time Frame: 1 year ]
    Is there a difference in length of stay at the hospital between the treatment groups

  9. Duration of clinical rehabilitation time [ Time Frame: 1 year ]
    Is there a difference in the duration of clinical rehabilitation time

  10. Duration of mechanical ventilation [ Time Frame: 1 year ]
    Is there a difference in the duration of mechanical ventilation between treatment groups

  11. Need for renal replacement therapy [ Time Frame: 1 year ]
    Is there a difference in need for renal replacement therapy between the treatment groups

  12. Acute kidney injury according to the RIFLE criteria [ Time Frame: 1 year ]
    Is there a difference in acute kidney injury according to the RIFLE criteria

  13. Time to target hypothermia [ Time Frame: 1 year ]
    Is there a difference in time to target hypothermia between the treatment groups

  14. Difference in metabolic markers between treatment groups [ Time Frame: 6 days ]
    Is there a difference in metabolic markers such as (1) pH, (2) etCO2, (3) ScVO2 and (4) lactate at arrival at the ED, right after initialization of circulation (either by ROSC or ECPR), 1, 2, 3, 4, 5 and 6 hours after return of circulation and at 1, 2, 3, 4, 5 and 6 days after the OHCA between the treatment groups

  15. Difference in metabolic markers between between the survivors and non-survivors [ Time Frame: 6 days ]
    Is there a difference in metabolic markers such as (1) pH, (2) etCO2, (3) ScVO2 and (4) lactate at arrival at the ED, right after initialization of circulation (either by ROSC or ECPR), 1, 2, 3, 4, 5 and 6 hours after return of circulation and at 1, 2, 3, 4, 5 and 6 days after the OHCA between the survivors and non-survivors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 - ≤70 years
  2. Witnessed OHCA (by bystanders)
  3. Initial rhythm of VF/VT or AED administered
  4. Bystander BLS

Exclusion Criteria:

  1. ROSC within 15 minutes of conventional CPR with sustained hemodynamic recovery
  2. Terminal heart failure (NYHA III or IV)
  3. Severe pulmonary disease (COPD GIII of GIV)
  4. Disseminated oncological disease
  5. Obvious or suspected pregnancy
  6. Bilateral femoral bypass surgery
  7. Known contraindications for ECPR
  8. Known pre-arrest CPC-score of 3 or 4
  9. Known limitations in therapy or a Do Not Resuscitate-order
  10. Multitrauma (Injury Severity Score >15)
  11. Expected time-to-start cannulation > 60 minutes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101787


Locations
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Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands
Academisch Medisch Centrum
Amsterdam, Noord-Holland, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Leids Universitair Medisch Centrum
Leiden, Zuid-Holland, Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands
HagaZiekenhuis
Den Haag, Netherlands
Erasmus MC
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Getinge Group
Investigators
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Principal Investigator: Marcel van de Poll, MD, PhD Maastricht UMC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03101787    
Other Study ID Numbers: NL58067.068.16
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
ECPR
Extracorporeal CardioPulmonary Resuscitation
OHCA
Out-of-Hospital Cardiac Arrest
CPR
CardioPulmonary Resuscitation
ECMO
ExtraCorporeal Membrane Oxygenation
Refractory Cardiac Arrest
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden