pulmonary hypertension
Conditions
Interventions
Sildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat d
Sponsors
Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfill all the criteria shown below are eligible for the trial. Patients with ages of 0 to 2 years at enrollment Patients who undergo surgery, 0pen heart surgery Left to Right shunt anomaly as following Ventricular septal defect(VSD) Atrial septal defect(ASD) Atrioventricular septal defect (AVSD) Patients who are followed up at ICU in Osaka Medical College or affiliated hospitals. Mean pulmonary arterial (PA) pressure is over 20 mmHg and/or the ratio of mean PA pressure / mean blood pressure is over 0.5.(measured after the surgery at ICU using a catheter put in the PA) Patients receive a standard management in the setting of the ICU with a specialized physician. Parents or guardians of the patients understand the significance of this trial with informed consent before surgery.
Exclusion criteria
Exclusion criteria: Patients with opened chest Patients with ventricular assist device Patients with extracorporeal membrane oxygenation Patients who are judged as inappropriate to include in this study. Patients with chronic lung disease, retinopathy, or gastrointestinal problems Patients who are received Nitrates or nitric oxide donors in non-intravenous form (oral, sublingual, buccal, transdermal, inhalation or aerosol) within 48 hours prior to receiving study drug treatment or intravenous forms within 2 hours prior to receiving study drug treatment (sildenafil is known to potentiate the hypotensive effects of nitrates; its concurrent use is contraindicated) Patients who are received endothelin antagonists(eg, bosentan) Patients who are received potent cytochrome P450 3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, and protease inhibitors) (Use of aprotinin will be allowed; aprotinin does not inhibit cytochrome P450 enzymes) Patients who are received ritonavir or nicorandil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean pulmonary arterial pressure after 4 hour administration from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| PAH crisis disappears Additional medication for PAH Successful wean from inhaled nitric oxide or other vasodilators Rebound PAH Duration of mechanical ventilation ICU stay | — |
Countries
Japan
Contacts
Public ContactShintaro Nemoto
Osaka Medical College Department of Thoracic and Cardiovascular Surgery
Outcome results
None listed