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Completed

NCT Number: NCT03101787

Early Initiation of Extracorporeal Life Support in Refractory OHCA

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht UMC, Maastricht, Limburg, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 - ≤70 years
  • Witnessed OHCA (by bystanders)
  • Initial rhythm of VF/VT or AED administered
  • Bystander BLS

Exclusion criteria

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

Treatment and study plan

Extracorporeal cardiopulmonary resuscitation (ECPR)

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Getinge Group
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)

Acronym: INCEPTION

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Apr 5, 2017
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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