An interventional study of Extracorporeal cardiopulmonary resuscitation (ECPR) in Cardiac Arrest, Out-Of-Hospital Cardiac Arrest and Sudden Cardiac Death, sponsored by Maastricht University Medical Center. Completed at 10 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 134 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
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Exclusion Criteria:
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.
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.
30-day survival rate with favorable neurological status
Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale
Time frame: 30 days
Neurological outcome on the CPC scale
Does ECPR improve the neurological outcome at 30 days, 3 months, 6 months and 12 months on the CPC scale
Time frame: 30 days, 3 months, 6 months and 12 months
Quality Adjusted Life Years (QALY's)
Does ECPR improve the amount of Quality Adjusted Life Years (QALY's) at 30 days, 3 months, 6 months and 12 months
Time frame: 30 days, 3 months, 6 months and 12 months
Reason for discontinuation of treatment between the treatment groups
Is there a difference in reason for discontinuation of treatment between the treatment groups
Time frame: Within 1 year
Time to return of circulation
What is the time to return of circulation
Time frame: Within 1 year
Additional costs of ECPR with respect to CCPR
What are the additional costs of ECPR with respect to CCPR
Time frame: 1 year
Costs per gained QALY for ECPR vs. CCPR
What are the costs per gained QALY for ECPR vs. CCPR
Time frame: 1 year
Length of stay at the ICU
Is there a difference in length of stay at the ICU between the treatment groups
Time frame: 1 year
Length of stay at the hospital
Is there a difference in length of stay at the hospital between the treatment groups
Time frame: 1 year
Duration of clinical rehabilitation time
Is there a difference in the duration of clinical rehabilitation time
Time frame: 1 year
Duration of mechanical ventilation
Is there a difference in the duration of mechanical ventilation between treatment groups
Time frame: 1 year
Need for renal replacement therapy
Is there a difference in need for renal replacement therapy between the treatment groups
Time frame: 1 year
Acute kidney injury according to the RIFLE criteria
Is there a difference in acute kidney injury according to the RIFLE criteria
Time frame: 1 year
Time to target hypothermia
Is there a difference in time to target hypothermia between the treatment groups
Time frame: 1 year
Difference in metabolic markers between treatment groups
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
Time frame: 6 days
Difference in metabolic markers between between the survivors and non-survivors
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
Time frame: 6 days
Plan to share: No
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Maastricht University Medical Center