Emergency Cardiopulmonary Bypass for Cardiac Arrest

NCT ID: NCT01605409

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2021-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard ACLS

Patients in the standard ACLS group will be resuscitated until ROSC or termination of efforts. If ROSC is achieved they will be transported to the emergency department and treated according to ERC guidelines and GCP.

Group Type: ACTIVE_COMPARATOR

Standard ACLS

Intervention Type: PROCEDURE

Standard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council.

Transportation:

Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital.

Standard Post resuscitation Management:

After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group.

If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible.

ECPB

ACLS provided for 15 minutes by EMS personnel according to current guidelines of the ERC.

CPR during transportation will be performed by EMS personnel according to ERC guidelines.

At the ED cannulation will be performed percutaneously if feasible. The femoral artery will be cannulated with a 17-19 - Fr and the femoral vein will be cannulated simultaneously with heparin coated 19-25 - Fr catheter or a smart cannula. An antegrade 8 - Fr cannula will be placed to supply perfusion for the cannulated leg if feasible. The procedures will be performed ultrasound-guided and the size of the cannulae will be adapted according to vessel size. Correct placement of the venous cannulae will be verified via ultrasound. Cardiopulmonary bypass will be performed by using the Lifebridge(Sorin®) or the Cardiohelp(Maquet®) ECMO device, according to protocol.

Group Type: EXPERIMENTAL

Emergency cardiopulmonary bypass under ongoing CPR

Intervention Type: PROCEDURE

Emergency cardiopulmonary bypass under ongoing CPR

Emergency cardiopulmonary bypass (ECMO: lifebridge (Sorin®) or cardiohelp(Maquet®) will be initiated percutaneously ultrasound guided, during CPR efforts at the Emergency department.

Cannulae and tubing in use will be heparin coated. ECMO flow will be set to 70ml/kgBW/min. Anticoagulation will achieved with unfractionated heparin and monitored using ACT.

Standard ACLS

Intervention Type: PROCEDURE

Standard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council.

Transportation:

Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital.

Standard Post resuscitation Management:

After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group.

If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible.

Interventions

Emergency cardiopulmonary bypass under ongoing CPR

Emergency cardiopulmonary bypass under ongoing CPR

Emergency cardiopulmonary bypass (ECMO: lifebridge (Sorin®) or cardiohelp(Maquet®) will be initiated percutaneously ultrasound guided, during CPR efforts at the Emergency department.

Cannulae and tubing in use will be heparin coated. ECMO flow will be set to 70ml/kgBW/min. Anticoagulation will achieved with unfractionated heparin and monitored using ACT.

Intervention Type: PROCEDURE

Standard ACLS

Standard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council.

Transportation:

Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital.

Standard Post resuscitation Management:

After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group.

If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients with witnessed out-of-hospital cardiac arrest, with presumed cardiac cause, immediate initiation of bystander CPR and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support are eligible. Patients who do achieve ROSC at first but suffer rearrest afterwards and do not achieve ROSC again after 15 minutes of advanced cardiac life support are considered eligible as well.

Exclusion Criteria

• Patients younger than 18 years or older than 75 years
• Traumatic cardiac arrest
• Cardiac arrest due to exsanguination, strangulation, hanging or drowning
• Accidental hypothermia as a cause of cardiac arrest
• Women suffering life-threatening amniotic fluid embolism
• Cardiac arrest due to pulmonary artery embolism
• Cardiac arrest due to intoxication
• Cardiac arrest due to intracranial hemorrhage
• Other initial ECG-rhythm than ventricular fibrillation
• Known or clinically apparent pregnancy
• Patients with an Allow-natural-death- (AND) or Do-not-attempt-resuscitation (DNAR) order or patients with a terminal illness
• Patients who, for any reason, can not be transported with ongoing CPR
• Insufficient quality of bystander CPR (at the discretion of the emergency physician or EMT)*
• Estimated transportation time exceeding 30 minutes
• Patients with psychiatric conditions
• Mentally handicapped patients
• Patients with severe neurological conditions
• Patients of a nursing institution or other institutionalized patients
• Ward of the state / prisoner

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Andreas Schober

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Schober, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna, Austria, Dept. of Emergency Medicine

Locations

Medical University Vienna, Dept. of Emergency Medicine

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Andreas Schober, MD

Role: CONTACT

andreas.schober@meduniwien.ac.at

+4340400 ext. 1964

Michael Holzer, Prof. MD

Role: CONTACT

michael.holzer@meduniwien.ac.at

+4340400 ext. 1964

Facility Contacts

Anton N. Laggner, Prof. MD

Role: primary

anton.laggner@meduniwien.ac.at

+43140400 ext. 1964

Other Identifiers

KLI196

Identifier Type: -

Identifier Source: org_study_id