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

Primary Purpose

Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Sudden Cardiac Death

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Extracorporeal cardiopulmonary resuscitation (ECPR)
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring ECPR, Extracorporeal CardioPulmonary Resuscitation, OHCA, Out-of-Hospital Cardiac Arrest, CPR, CardioPulmonary Resuscitation, ECMO, ExtraCorporeal Membrane Oxygenation, Refractory Cardiac Arrest

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht UMC
  • Catharina Ziekenhuis
  • Academisch Medisch Centrum
  • Isala Klinieken
  • St. Antonius Hospital
  • Leids Universitair Medisch Centrum
  • Onze Lieve Vrouwen Gasthuis
  • HagaZiekenhuis
  • Erasmus MC
  • Universitair Medisch Centrum Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CCPR protocol

ECPR protocol

Arm Description

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.

Outcomes

Primary Outcome Measures

30-day survival rate with favorable neurological status
Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale

Secondary Outcome Measures

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
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
Reason for discontinuation of treatment between the treatment groups
Is there a difference in reason for discontinuation of treatment between the treatment groups
Time to return of circulation
What is the time to return of circulation
Additional costs of ECPR with respect to CCPR
What are the additional costs of ECPR with respect to CCPR
Costs per gained QALY for ECPR vs. CCPR
What are the costs per gained QALY for ECPR vs. CCPR
Length of stay at the ICU
Is there a difference in length of stay at the ICU between the treatment groups
Length of stay at the hospital
Is there a difference in length of stay at the hospital between the treatment groups
Duration of clinical rehabilitation time
Is there a difference in the duration of clinical rehabilitation time
Duration of mechanical ventilation
Is there a difference in the duration of mechanical ventilation between treatment groups
Need for renal replacement therapy
Is there a difference in need for renal replacement therapy between the treatment groups
Acute kidney injury according to the RIFLE criteria
Is there a difference in acute kidney injury according to the RIFLE criteria
Time to target hypothermia
Is there a difference in time to target hypothermia between the treatment groups
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
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

Full Information

First Posted
March 30, 2017
Last Updated
October 14, 2022
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Getinge Group
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1. Study Identification

Unique Protocol Identification Number
NCT03101787
Brief Title
Early Initiation of Extracorporeal Life Support in Refractory OHCA
Acronym
INCEPTION
Official Title
Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Getinge Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Sudden Cardiac Death
Keywords
ECPR, Extracorporeal CardioPulmonary Resuscitation, OHCA, Out-of-Hospital Cardiac Arrest, CPR, CardioPulmonary Resuscitation, ECMO, ExtraCorporeal Membrane Oxygenation, Refractory Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCPR protocol
Arm Type
No Intervention
Arm Description
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.
Arm Title
ECPR protocol
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Extracorporeal cardiopulmonary resuscitation (ECPR)
Intervention Description
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 Measure Information:
Title
30-day survival rate with favorable neurological status
Description
Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Neurological outcome on the CPC scale
Description
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
Title
Quality Adjusted Life Years (QALY's)
Description
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
Title
Reason for discontinuation of treatment between the treatment groups
Description
Is there a difference in reason for discontinuation of treatment between the treatment groups
Time Frame
Within 1 year
Title
Time to return of circulation
Description
What is the time to return of circulation
Time Frame
Within 1 year
Title
Additional costs of ECPR with respect to CCPR
Description
What are the additional costs of ECPR with respect to CCPR
Time Frame
1 year
Title
Costs per gained QALY for ECPR vs. CCPR
Description
What are the costs per gained QALY for ECPR vs. CCPR
Time Frame
1 year
Title
Length of stay at the ICU
Description
Is there a difference in length of stay at the ICU between the treatment groups
Time Frame
1 year
Title
Length of stay at the hospital
Description
Is there a difference in length of stay at the hospital between the treatment groups
Time Frame
1 year
Title
Duration of clinical rehabilitation time
Description
Is there a difference in the duration of clinical rehabilitation time
Time Frame
1 year
Title
Duration of mechanical ventilation
Description
Is there a difference in the duration of mechanical ventilation between treatment groups
Time Frame
1 year
Title
Need for renal replacement therapy
Description
Is there a difference in need for renal replacement therapy between the treatment groups
Time Frame
1 year
Title
Acute kidney injury according to the RIFLE criteria
Description
Is there a difference in acute kidney injury according to the RIFLE criteria
Time Frame
1 year
Title
Time to target hypothermia
Description
Is there a difference in time to target hypothermia between the treatment groups
Time Frame
1 year
Title
Difference in metabolic markers between treatment groups
Description
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
Title
Difference in metabolic markers between between the survivors and non-survivors
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel van de Poll, MD, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC
City
Maastricht
State/Province
Limburg
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Noord-Brabant
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
Country
Netherlands
Facility Name
Onze Lieve Vrouwen Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
HagaZiekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30738245
Citation
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.
Results Reference
derived

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Early Initiation of Extracorporeal Life Support in Refractory OHCA

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