The microcirculation in children treated with extracorporeal membrane oxygenation; an observational longitudinal study

The microcirculation in children treated with extracorporeal membrane oxygenation; an observational longitudinal study - Microcirculatory changes during ECMO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34390

Enrollment

Registered

2010-12-15

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory and/or cardiac failure

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The main study endpoint is (*) microcirculatory perfusion (defined by the parameters PVD & MFI) at 2h and at 24h after ECMO cannulation. This will be evaluated for VA-ECMO and VV-ECMO patients separately.	—

Secondary

Measure	Time frame
- () Microcirculatory perfusion (defined by the parameters PVD & MFI) at D1-D6 in VA-ECMO patients as compared to () microcirculatory perfusion at D1-D6 in VV-ECMO patients. - () Microcirculatory perfusion (defined by the parameters PVD & MFI) at 12h before and at 12h and 24h after ECMO decannulation. This will be evaluated for VA-ECMO and VV-ECMO patients separately. - The incidence of mortality within the first 28 days after (decannulation of) ECMO - () Microcirculatory perfusion (defined by the parameters PVD & MFI) in VA-ECMO patients during ECMO flow class I (flow * 50 ml/kg/min), ECMO flow class II (50 ml/kg/min	—

Measure

Time frame

- (*) Microcirculatory perfusion (defined by the parameters PVD & MFI) at D1-D6 in VA-ECMO patients as compared to (*) microcirculatory perfusion at D1-D6 in VV-ECMO patients. - (*) Microcirculatory perfusion (defined by the parameters PVD & MFI) at 12h before and at 12h and 24h after ECMO decannulation. This will be evaluated for VA-ECMO and VV-ECMO patients separately. - The incidence of mortality within the first 28 days after (decannulation of) ECMO - (*) Microcirculatory perfusion (defined by the parameters PVD & MFI) in VA-ECMO patients during ECMO flow class I (flow * 50 ml/kg/min), ECMO flow class II (50 ml/kg/min

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Countries

Netherlands

Outcome results