Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| 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 |
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.