Evidence based therapy of pulmonary hypertension in congenital diaphragmatic hernia - A prospective observational study

Evidence based therapy of pulmonary hypertension in congenital diaphragmatic hernia - A prospective observational study - Evidence based therapy CDH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35811

Enrollment

Registered

2011-10-19

Start date

2011-07-01

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

high pulmonary resistance pulmonary hypertension

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: All patients with congenital diaphragmatic hernia admitted to the ICU Written parental informed consent

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results