To study whether microcirculatory perfusion is improved by ECMO. Perfusion will be studied before & after ECMO start, during ECMO weaning and before & after ECMO stop. To study the precictive value of perfusion and its correlation with the…
ID
Source
Brief title
Condition
- Red blood cell disorders
- Cardiac disorders, signs and symptoms NEC
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- (*) 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 < flow * 150 ml/kg/min) and ECMO flow class III (ECMO
flow * 150 ml/kg/min).
- (*) Microcirculatory perfusion (defined by the parameters PVD & MFI) in
VA-ECMO and VV-ECMO patients separately in correlation to other macro- and
microcirculatory parameters (in order of importance: vasopressor score, ECMO
flow, lactate, skin temperature, pH, core body temperature, Hb, Ht, MAP, SvO2,
pre- and postductal saturation and HF).
- (*) Microcirculatory perfusion (defined by the parameters PVD & MFI) and
tissue oxygenation (defined by the parameters rSO2 & FOE) 2 and 24 hours after
RBC transfusion. This will be evaluated for VA-ECMO, VV-ECMO and postsurgical
patients separately.
Background summary
Children with therapy resistant (cardio)respiratory failure are eligible for
extracorporeal membrane oxygenation (ECMO). In essence, ECMO is intended to
improve tissue perfusion and oxygenation at the cellular level thereby
decreasing mortality. After ECMO initiation, macrocirculatory and respiratory
parameters improve instantly. However, ECMO initiation is also associated with
detrimental microcirculatory factors such as severe inflammatory response
syndrome, non-pulsatile blood flow and possibly, transfusions with stored red
blood cells. As there is evidence to suspect a discrepancy between macro- and
microcirculation, monitoring of microcirculatory perfusion is important.
Moreover, there is a diagnostic gap regarding tissue perfusion. Monitoring
microcirculatory perfusion before during and after ECMO might prove to be
useful not only to evaluate the efficacy of ECMO, but might help to optimize
ECMO treatment as well. Limited studies have been performed using non-invasive
functional biomarkers to study the microcirculation in critically ill children
and ECMO patients in particular.
Study objective
To study whether microcirculatory perfusion is improved by ECMO. Perfusion will
be studied before & after ECMO start, during ECMO weaning and before & after
ECMO stop. To study the precictive value of perfusion and its correlation with
the macrocirculation. To study the microcirculatory effects of RBC transfusion
during ECMO.
Study design
Investigator initiated, single center, observational, prospective cohort study
Study burden and risks
Subjects will have no direct benefits of participating in this study. We aim to
assess the objectives using a non-invasive, functional biomarker tool called
Sidestream Dark Field Imaging (SDF). No adverse events have been reported using
SDF. The expected burden for participants is very low, as the study procedure
is non-invasive and no radiation or other known damaging factors are involved.
Total study procedure will take maximally 5 minutes for each measurement. The
only possible burden could be that measurements need to be performed before,
during and after ECMO and that some minor manipulation may be required to
obtain qualitatively good measurements. Standard, protocolized therapy will be
monitored as this is an observational study. Other than SDF, patients will not
be exposed to any additional medical or diagnostic procedures, nor will medical
or diagnostic procedures be postponed due to SDF measurements.
Dr. Molewaterplein 60
Postbus 2060, 3000 CB Rotterdam
NL
Dr. Molewaterplein 60
Postbus 2060, 3000 CB Rotterdam
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34017.078.10 |