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CompletedNCT03592810

Observational Study to Assess Optimal ECPR Settings After Resuscitation

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

Status
Completed
Phase
Study type
Observational
Enrollment
26 (actual)
Sponsor
Erasmus Medical Center · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERSettings 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

Timeline

Start date
2018-07-18
Primary completion
2020-03-01
Completion
2020-09-30
First posted
2018-07-19
Last updated
2021-02-23

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT03592810. Inclusion in this directory is not an endorsement.