Emergency Cardiopulmonary Bypass for Cardiac Arrest

NCT01605409 | Unknown

• 1 other identifier: KLI196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Refractory cardiac arrest; Emergency cardiopulmonary bypass; Extracorporeal life support in cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Rate of return of spontaneous circulation (ROSC)

  2-48h

Study Arms (2)

Standard ACLS

ACTIVE COMPARATOR

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.

Procedure: Standard ACLS

ECPB

EXPERIMENTAL

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.

Procedure: Emergency cardiopulmonary bypass under ongoing CPR; Procedure: Standard ACLS

Interventions

Emergency cardiopulmonary bypass under ongoing CPR 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.

ECPB

Standard ACLS 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; Standard ACLS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna, Dept. of Emergency Medicine

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Andreas Schober, MD

  Medical University Vienna, Austria, Dept. of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Schober, MD

CONTACT

+4340400; andreas.schober@meduniwien.ac.at

Michael Holzer, Prof. MD

CONTACT

+4340400; michael.holzer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: November 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

AU (1)