Observational Study to Assess Optimal ECPR Settings After Resuscitation

Cardiac Arrest Clinical Trial

— MOFE  

Official title:

Multi-center Observational Study to Assess Optimal ECMO Settings During the First Hours of Extracorporeal Cardiopulmonary Resuscitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592810
• Other study ID #: NL60632.078.17
• Status: Completed
• Start date: July 18, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to minimize ischemia-reperfusion injury of the brain.

Objective: In this study, we want to elaborate on the optimal ECMO settings in the first three hours after initiation of ECPR.

Study design: Prospective, multi-centre, observational study Study population: All patients receiving ECPR in the age between 18 and 70 years, with low flow duration<60min and receiving cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients.

Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific enolase (NSE) will be determined from routine blood drawings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 30, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement)

• Age>18 and < 70 years

• Duration of low-flow < 60 min before decision to proceed with ECPR

• High quality CPR (defined as end-tidal carbon dioxide (CO2et) >10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC)

• Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG)

• Cerebral oxymetry monitoring initiated during CPR preceding ECPR

Exclusion Criteria:

• Patients with a GCS<15 before CPR.

• Known pre-arrest cerebral performance category CPC = 3

• Presumed noncardiac cause

• Unwitnessed collapse

• Suspected or confirmed pregnancy

• ROSC within 5 minutes of Advanced cardiopulmonary life support (ACLS) performed by emergency medical service (EMS) team

• Conscious patient

• Known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding

• Suspected or confirmed acute stroke

• Known severe chronic organ dysfunction or other limitations to therapy

• "Do not resuscitate" order or other circumstances that make 180 day survival unlikely

Related Conditions & MeSH terms

• Cardiac Arrest
• Extracorporeal Cardiopulmonary Resuscitation
• Heart Arrest

Intervention

Other:
• Settings of the extracorporeal membrane oxygenation (ECMO)
Compare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPC score 6 months	To prospectively identify parameters correlated with Cerebral Performance Category (CPC)* = 2	6 months
Secondary	CPC score discharge	Parameters correlated with a CPC* = 2	6 months
Secondary	Glasgow coma scale (GCS) day 28	Parameters correlated with a GCS>13	6 months
Secondary	GCS total	Parameters correlated with a GCS > 13	6 months
Secondary	28 day mortality	Parameters correlated to 28 days mortality	6 months
Secondary	Hospital survival	Parameters correlated to hospital survival	6 months