Early Initiation of Extracorporeal Life Support in Refractory OHCA

Cardiac Arrest Clinical Trial

— INCEPTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101787
• Other study ID #: NL58067.068.16
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: February 10, 2022

Study information

• Verified date: August 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Sudden Cardiac Death

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam	Noord-Holland
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Netherlands	HagaZiekenhuis	Den Haag
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	Maastricht UMC	Maastricht	Limburg
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
Netherlands	Erasmus MC	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Getinge Group, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day survival rate with favorable neurological status	Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale	30 days
Secondary	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	30 days, 3 months, 6 months and 12 months
Secondary	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	30 days, 3 months, 6 months and 12 months
Secondary	Reason for discontinuation of treatment between the treatment groups	Is there a difference in reason for discontinuation of treatment between the treatment groups	Within 1 year
Secondary	Time to return of circulation	What is the time to return of circulation	Within 1 year
Secondary	Additional costs of ECPR with respect to CCPR	What are the additional costs of ECPR with respect to CCPR	1 year
Secondary	Costs per gained QALY for ECPR vs. CCPR	What are the costs per gained QALY for ECPR vs. CCPR	1 year
Secondary	Length of stay at the ICU	Is there a difference in length of stay at the ICU between the treatment groups	1 year
Secondary	Length of stay at the hospital	Is there a difference in length of stay at the hospital between the treatment groups	1 year
Secondary	Duration of clinical rehabilitation time	Is there a difference in the duration of clinical rehabilitation time	1 year
Secondary	Duration of mechanical ventilation	Is there a difference in the duration of mechanical ventilation between treatment groups	1 year
Secondary	Need for renal replacement therapy	Is there a difference in need for renal replacement therapy between the treatment groups	1 year
Secondary	Acute kidney injury according to the RIFLE criteria	Is there a difference in acute kidney injury according to the RIFLE criteria	1 year
Secondary	Time to target hypothermia	Is there a difference in time to target hypothermia between the treatment groups	1 year
Secondary	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	6 days
Secondary	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	6 days