The microcirculation in children treated with extracorporeal membrane oxygenation; an observational longitudinal study
- Conditions
- respiratory and/or cardiac failure100381581008220610028971
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Group 1 & 2:
-Patients admitted to the (neonatal and/or pediatric) IC of Erasmus MC-Sophia, in need of ECMO either due to pathology for which they are primarily admitted or due to secondary pathology which originates during their admittance in the IC.
- Parental informed consent before ECMO obtained by using the short patient information letter (PIF no. 1; see Ch. 8.2 research protocol) and parental informed consent obtained within 24h after ECMO start obtained by using the regular PIF (PIF no. 2; see Ch. 8.2 research protocol)
-Patients in group 2 will be matched 1 on 1 to patients in group 1 for gender and age (± 6 months);Group 3:
- Term patients admitted to the IC of Erasmus MC-Sophia in need of RBC transfusion after surgery (e.g. patients after craniofacial surgery, patients after cardiac surgery)
- Parental informed consent
- Patients in group 3 will be matched 1 on 1 to patients in group 1 for gender and age (± 1 month)
Group 1 & 2:
- Age * 18 years
- Rapid response ECMO outside the IC of Erasmus MC-Sophia
- Transfer on ECMO to the IC of Erasmus MC-Sophia (including the dept. of thoracic surgery of Erasmus MC-Sophia)
- Unsuccessful cannulation and/or inability to generate sufficient blood flow
- ECMO exclusion criteria (e.g. weight < 2kg., irreversible pathology);Group 3:
- Preterm infants
- Age * 18 years
- RBC transfusion by irradiated blood cell products
- RBC transfusion of blood cell savers
- Term patients diagnosed with malignancy (hematologic and/or solid organ)
- Term patients diagnosed with hemoglobinopathy of any kind
- Term patients diagnosed with bone marrow disease of any kind
- Cardiopulmonary resuscitation and subsequent therapeutic hypothermia
- Severe pathology which imply abstinence of therapy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is (*) microcirculatory perfusion (defined by the<br /><br>parameters PVD & MFI) at 2h and at 24h after ECMO cannulation. This will be<br /><br>evaluated for VA-ECMO and VV-ECMO patients separately. </p><br>
- Secondary Outcome Measures
Name Time Method