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Completed

NCT Number: NCT03592810

Observational Study to Assess Optimal ECPR Settings After Resuscitation

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.

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Key information

Conditions

Extracorporeal Cardiopulmonary Resuscitation Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ErasmusMC

Rotterdam, 3015, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Settings of the extracorporeal membrane oxygenation (ECMO)

Other

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

Other names: Measurements of cerebral saturation

Primary outcomes

  1. CPC score 6 months

    Time frame: 6 months

    To prospectively identify parameters correlated with Cerebral Performance Category (CPC)* ≤ 2

Secondary outcomes

  1. CPC score discharge

    Time frame: 6 months

    Parameters correlated with a CPC* ≤ 2

  2. Glasgow coma scale (GCS) day 28

    Time frame: 6 months

    Parameters correlated with a GCS>13

  3. GCS total

    Time frame: 6 months

    Parameters correlated with a GCS > 13

  4. 28 day mortality

    Time frame: 6 months

    Parameters correlated to 28 days mortality

  5. Hospital survival

    Time frame: 6 months

    Parameters correlated to hospital survival

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: MOFE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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