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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

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 5, 2017
Last Update Posted Date October 18, 2022
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date February 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2022)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
30-day survival rate with favorable neurological status [ Time Frame: 30 days ]
Favorable neurological status is defined as 1 or 3 on the using Cerebral Performance Category scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2022)
  • 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
  • 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
  • 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
  • Time to return of circulation [ Time Frame: Within 1 year ]
    What is the time to return of circulation
  • Additional costs of ECPR with respect to CCPR [ Time Frame: 1 year ]
    What are the additional costs of ECPR with respect to CCPR
  • Costs per gained QALY for ECPR vs. CCPR [ Time Frame: 1 year ]
    What are the costs per gained QALY for ECPR vs. CCPR
  • 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
  • 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
  • Duration of clinical rehabilitation time [ Time Frame: 1 year ]
    Is there a difference in the duration of clinical rehabilitation time
  • Duration of mechanical ventilation [ Time Frame: 1 year ]
    Is there a difference in the duration of mechanical ventilation between treatment groups
  • Need for renal replacement therapy [ Time Frame: 1 year ]
    Is there a difference in need for renal replacement therapy between the treatment groups
  • 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
  • Time to target hypothermia [ Time Frame: 1 year ]
    Is there a difference in time to target hypothermia between the treatment groups
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • QALY's [ Time Frame: 3 months, 6 months and 1 year ]
    Quality-adjusted-life-years using EQ-5D-5L
  • Costs of ECPR and CCPR [ Time Frame: 3 months, 6 months and 1 year ]
    Using the CRF, iPCQ and iMCQ
  • Survival status at 3 months, 6 months and 1 year [ Time Frame: 3 months, 6 months and 1 year ]
  • Neurologic status at 3 months, 6 months and 1 year [ Time Frame: 3 months, 6 months and 1 year ]
    Favorable neurological status is defined as 1 or 3 on the using Cerebral Performance Category scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Initiation of Extracorporeal Life Support in Refractory OHCA
Official Title  ICMJE Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Arrest
  • Out-Of-Hospital Cardiac Arrest
  • Sudden Cardiac Death
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)
Publications * Bol ME, Suverein MM, Lorusso R, Delnoij TSR, Brandon Bravo Bruinsma GJ, Otterspoor L, Kuijpers M, Lam KY, Vlaar APJ, Elzo Kraemer CV, van der Heijden JJ, Scholten E, Driessen AHG, Montero Cabezas JM, Rittersma SZH, Heijnen BG, Taccone FS, Essers B, Delhaas T, Weerwind PW, Roekaerts PMHJ, Maessen JG, van de Poll MCG. Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest: Design and rationale of the INCEPTION trial. Am Heart J. 2019 Apr;210:58-68. doi: 10.1016/j.ahj.2018.12.008. Epub 2018 Dec 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2022)
134
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2017)
110
Actual Study Completion Date  ICMJE February 10, 2022
Actual Primary Completion Date February 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03101787
Other Study ID Numbers  ICMJE NL58067.068.16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Maastricht University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Maastricht University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Getinge Group
Investigators  ICMJE
Principal Investigator: Marcel van de Poll, MD, PhD Maastricht UMC
PRS Account Maastricht University Medical Center
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP