Observational Study to Assess Optimal ECPR Settings After Resuscitation

NCT03592810 | Completed

• 1 other identifier: NL60632.078.17
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extracorporeal Cardiopulmonary Resuscitation; Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• CPC score 6 months

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

  6 months

Secondary Outcomes (5)

• CPC score discharge

  6 months

• Glasgow coma scale (GCS) day 28

  6 months

• GCS total

  6 months

• 28 day mortality

  6 months

• Hospital survival

  6 months

Study Arms (1)

ECPR

All patients who received ECMO placement during cardiopulmonary resuscitation (ECPR)

Other: Settings of the extracorporeal membrane oxygenation (ECMO)

Interventions

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

Also known as: Measurements of cerebral saturation

ECPR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients receiving ECPR will be included. The decision to perform an ECPR is made by the local protocol and clinical judgment of the attending physician.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, 3015, Netherlands

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dinis dos Reis Miranda, PhD, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 19, 2018
• Study Start: July 18, 2018
• Primary Completion: March 1, 2020
• Study Completion: September 30, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)