Pulmonary Hypertension
Conditions
Keywords
pediatric, cardiac, sildenfil, milrinone, pulmonary hypertension
Brief summary
Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements. Pulmonary arterial hypertension is a frequent complication of congenital heart disease, particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP ratio of \< 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension, and a ratio of \> 0.5 is indicative of severe pulmonary hypertension
Detailed description
30 Patients were randomly allocated in two equal groups; group MS (received intravenous milrinone and oral sildenafil) and group M (received only intravenous milrinone). Demographic data, patient's clinical data and different intraoperative times were recorded. In 1st postoperative 24 hours, we recorded; hemodynamic parameters \[mean pulmonary arterial pressure (MPAP), mean systemic arterial pressure (MAP), heart rate, central venous pressure\]. We calculated MPAP/MAP and inotropic score. The incidence of pulmonary hypertensive crisis, side effects of studied drugs and complications related to pulmonary artery catheter were recorded.
Interventions
DRUGmilrinone
IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study.
DRUGSildenafil
IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study. After baseline measurements, sildenafil (1mg/kg) administered in ICU via a nasogastric tube, to be repeated every 4 hours via a nasogastric tube or orally. Sildnafil is presented in tablet form which was dissolved in water to make a concentration of 1 mg/ml.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
\- Thirty patients in the age range 2-24 months scheduled for surgical closure of ventricular septal defect (VSD) associated with postoperative pulmonary hypertension \[diagnosed in all patients by preoperative echocardiography and confirmed invasively by the pulmonary catheter before transfer to ICU by Mean Pulmonary Arterial Pressure (MPAP) \> 25 mmHg or Mean Pulmonary Arterial Pressure (MPAP) /Mean Systemic Arterial Pressure (MAP) \> 0.33\] were enrolled in this study.
Exclusion criteria
* Patients with pre-existing obstructive lung disease, mitral valve disease, left ventricular dysfunction, and patients receiving preoperative pulmonary vasodilators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean pulmonary arterial pressure | within the first 24 hours postoperative |
Secondary
| Measure | Time frame |
|---|---|
| mean systemic blood pressure | within the first 24 hours postoperative |
| pulmonary hypertensive crisis | within the first 4 days postoperative |
Outcome results
None listed