Cardiac Arrest Clinical Trial
Official title:
Emergency Cardiopulmonary Bypass After Cardiac Arrest With Ongoing Cardiopulmonary Resuscitation - a Pilot Randomized Trial
Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation
algorithms and postcardiac arrest care have been improved there is an urgent need for
measures leading to a higher survival rate.
Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body)
is a method which has shown good results in case reports and animal studies for cardiac
arrest care.
The study will be performed as comparison between the new treatment option of ECPB versus the
standard of care treatment.
Aim of our study is to determine the feasibility of ECPB installed in an emergency department
to improve the rate of patients restoration of spontaneous circulation.
Background: Out of hospital cardiac arrest is associated with a poor prognosis. Overall
survival varies between 3% and 16% respectively. Measures to improve the chance of survival
are urgently needed. If return of spontaneous circulation under competent cardiopulmonary
resuscitation (CPR) measures is not achieved within the first 25 minutes the chance of
survival decreases even further. Emergency Cardiopulmonary Bypass (ECPB) would be such a
treatment option for these heavily compromised patients, as it has shown considerably good
results used as resuscitation device for cardiac arrest in animal studies.
Material and Methods: This study will be performed as single center (university hospital)
randomized, controlled and prospective pilot study comprising a highly experienced emergency
department treating about 200 to 300 cardiac arrest patients a year. Two groups will be
analyzed, a `Standard ACLS´ group and an `ECPB´ group. Each group will comprise 20 patients.
Eligible are adult patients with witnessed out of hospital cardiac arrest, with presumed
cardiac cause and without return of spontaneous circulation after a minimum of 15 minutes of
advanced cardiac life support.
Patients in the `Standard ACLS´ group will be resuscitated until return of spontaneous
circulation or termination of efforts. The `ECPB´ group will receive ongoing cardiopulmonary
resuscitation during transport to the emergency department where ECPB will be installed.
Necessary diagnostic examinations and therapeutic interventions for both groups will be
performed according to guidelines for post resuscitation care and good clinical practice.
Primary outcome measure is the rate of sustained restoration of spontaneous circulation
according to Utstein criteria. Secondary outcome measures are 24 hours survival, survival to
ICU discharge, survival to hospital discharge, rate of best neurological recovery (cerebral
performance category score 1 or 2) within 6 months after cardiac arrest and modified Rankin
score at 6 months after cardiac arrest.
Patients in the `Standard ACLS´ group receive standard treatment without any potential
additional risks. The `ECPB´ group receives standard advanced cardiac life support as well
and has the predicted advantage of the extracorporeal oxygenation at the emergency department
and coronary intervention even before return of spontaneous circulation.
Aim of this study: To compare current standard therapy for patients after out of hospital
cardiac arrest (cardiopulmonary resuscitation until return of spontaneous circulation or
termination of efforts) with a new concept of transportation with ongoing cardiopulmonary
reanimation and installation of ECPB at the Emergency Department to improve survival.
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