To evaluate the predictive value of microcirculatory perfusion for the incidence of Extracorporeal Membrane Oxygenation (ECMO) dependency and consequently survival. To evaluate the effects of vasopressor drugs and iNO on microcirculatory perfusion…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the incidence of ECMO dependency within the first
day 28 of life and mortality within the first day 186 of life. Microcirculatory
perfusion (depicted by PVD & MFI) will be assessed within 1 hour after
admission for its predictive value.
Secondary outcome
To study microcirculatory perfusion in CDH patients on day 1 to 7 of life.
To study the effects of dobutamine, dopamine, epinephrine, norepinephrine (in
relation to the vasopressor score) and iNO on microcirculatory perfusion in CDH
patients.
To study the relation between microcirculatory perfusion (as measured by SDF)
and routinely obtained macrocirculatory and microcirculatory parameters in CDH
patients.
Background summary
Congenital diaphragmatic hernia (CDH) is a severe congenital (cardio)pulmonary
disease associated with high morbidity and mortality. However, the spectrum of
presentation and natural history are highly variable, varying from minimal or
no symptoms, to acute, severe respiratory distress and hemodynamic instability
with imminent death in the immediate newborn period. There is evidence to
suspect microcirculatory alterations in CDH patients, which might prove to be
independent from macrocirculatory alterations. Moreover, there is a diagnostic
gap regarding tissue perfusion. Microcirculatory perfusion might prove to be
not only predictive for morbidity and/or mortality, but might be informative
about the efficacy of vasopressor drugs and inhaled nitric oxide (iNO) as well.
Limited studies have been performed using non-invasive functional biomarkers to
study the microcirculation in critically ill children and CDH patients in
particular.
Study objective
To evaluate the predictive value of microcirculatory perfusion for the
incidence of Extracorporeal Membrane Oxygenation (ECMO) dependency and
consequently survival. To evaluate the effects of vasopressor drugs and iNO on
microcirculatory perfusion.
Study design
Investigator initiated, single center, observational, prospective case-control
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 daily for
day 1-7 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
3000CB, Rotterdam
NL
Dr. Molewaterplein 60, Postbus 2060
3000CB, Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Group 1: CDH patients
- Antenatal diagnosis of CDH
- Mother admitted to Obstetrics & Gynecology department, Erasmus MC-Sophia
- Parental informed consent ;Group 2: Control patients
Group 2A
- Control patients for group 1, matched for gender, PMA (±1 week) and age (± 1 day).
- Admittance to IC of Erasmus MC-Sophia
- Congenital malformations of the digestive tract
- Parental informed consent;Group 2B
- Control patients for group 1, matched for gender, PMA (±1 week) and age (± 1 day).
- Born in the Obstetrics & Gynecolgy department of Erasmus MC-Sophia
- Mother admitted to the Obstetrics & Gynecolgy department of Erasmus MC-Sophia
- Parental informed consent
Exclusion criteria
Group 1: CDH patients
- Non-antenatal diagnosis of CDH
- Outborn CDH patients
- Recurrent CDH
- Lung pathology mimicking diagnostic or clinical signs of CDH (diseases which should be excluded are diaphragmatic eventration, congenital cystic adenomatoid malformation (CCAML), bronchopulmonary sequestration, bronchogenic cysts, bronchial atresia, enteric cysts and teratomas)
- Severe chromosomal anomaly (i.e. trisomy 13 or trisomy 18), which imply abstinence of therapy
- Severe congenital cardiac anomaly (i.e. transposition of the great arteries, double outlet right ventricle, truncus arteriosus) with the exception of cardiac deformations associated with CDH (i.e. PDA, patent foramen ovale (PFO), small atrioventricular (AVSD) or atrioseptal defect (ASD))
- Cardiopulmonary resuscitation and subsequent therapeutic hypothermia;Group 2: Control patients
Group 2A & Group 2B
- Congenital anomalies or pathology of any kind known to influence cardiorespiratory functioning
- Use of vasopressor(s) (i.e. dobutamine, dopamine, epinephrine, norepinephrine) and/or iNO 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 | NL32437.078.10 |