The primary objective is to determine if echocardiography in combination with plasma biomarkers can be used as a potential predictor for pulmonary hypertension. The secondary objectives are assessment of a potential correlation between…
ID
Source
Brief title
Condition
- Heart failures
- Gastrointestinal tract disorders congenital
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are echocardiographic signs of pulmonary hypertension
in combination with plasma biomarkers (ICAM, VCAM, sP-selectin, VEGF, von
Willebrand factor, thrombomodulin, activated factor VIII:C, nitrate, nitrite,
ADMA, NT.pro BNP).
Secondary outcome
Microcirculatory perfusion (defined by the parameters PVD and MFI) at day 1-7
and at 2 hours after start of iNO, sildenafil and bosentan
Correlation with lactate, pH, MAP, pre- and postductal saturation, HF, Hb, Ht,
oxygen demand, need of ventilation
Drug and metabolite concentrations of sildenafil and bosentan
Population PK analysis
Pharmacodynamic analysis
Background summary
The development of pulmonary hypertension in infants born with a congenital
diaphragmatic hernia has a major impact on the outcome concerning the mortality
and morbidity. Although the treatment has been improving over the last years,
there are limited studies using macro- and mircocirculatory parameters in
combination with plasmabiomarkers to follow the changes in pulmonary
hypertension in these infants during therapy.
Study objective
The primary objective is to determine if echocardiography in combination with
plasma biomarkers can be used as a potential predictor for pulmonary
hypertension. The secondary objectives are assessment of a potential
correlation between microcirculatory (SDF) and macrocirculatory
(echocardiography) parameters and to study the effect of medical therapy with
sildenafil and bosentan using pharmacokinetic and pharmacodynamic analysis.
Study design
Investigator initiated, single center, observational, prospective study.
Study burden and risks
Subjects will have no direct benefits of participating in this study. We aim to
assess the objectives using echocardiography, Sidestream Dark Field Imaging
(SDF), plasma biomarkers and as indicated drug and metabolite concentrations of
sildenafil and bosentan. No adverse events have been reported using
echocardiography and SDF. The expected burden for participants is very low, as
the study procedure (echocardiography and SDF) is non-invasive and no radiation
or other known damaging factors are involved. Total study procedure will take
maximally 30 minutes (echocardiography) and 5 minutes (SDF) for each
measurement. Standard, protocolized therapy will be monitored as this is an
observational study. Other than echocardiography, SDF, plasma biomarkers and
drug and metabolite concentrations patients will not be exposed to any
additional medical or diagnostic procedures. No medical or diagnostic
procedures will be postponed due to these measurements.
Dr molenwaterplein 60
3015GJ Rotterdam
NL
Dr molenwaterplein 60
3015GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
All patients with congenital diaphragmatic hernia admitted to the ICU
Written parental informed consent
Exclusion criteria
Out born patients with congenital diaphragmatic hernia
Recurrent congenital diaphragmatic hernia
Lung pathology mimicking diagnostic or clinical signs of congenital diaphragmatic hernia
Severe chromosomal anomaly which imply abstinence of therapy
Severe congenital cardiac anomaly with the exception of cardiac deformations associated with congenital diaphragmatic hernia (patent ductus arteriosus, patent foramen ovale, atrioseptal defect)
Cardiopulmonary resuscitation and subsequent therapeutic hypothermia
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 | NL36587.078.11 |