Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD
Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.
Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iloprost nebuliser solusion | Experimental | 50 ng/kg/min |
|
| distilled water | Placebo Comparator | 2ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iloprost nebuliser solusion | Drug | 50 ng/kg/min inhalation for 10 minutes, q2h for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary end point is a composite variable (incidence rate of any events) consisting of reactive PH, PHC and death requiring additional pharmacological or other support administered within the first 48 hours after receiving study drug. | Reactive PH is defined as Pp/Ps greater than 0.5 for more than 30min. End point of observation: in case of Pp/Ps greater than 0.5 for more than 30min or Pp/Ps greater than 1 for any time period, drug inhalation will be immediately stopped and other therapies such as NO inhalation and/or iloprost 80 ng/kg/min inhalation will be resorted to treat pulmonary hypertension. | The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from base line of pulmonary heamodynamic measurements: Pp/Ps, PVRI, SVRI | The heamodynamic variable is measured before, after iloprost inhalation instantly and 30-min later. |
Not provided
Inclusion Criteria:
Before corrective procedure for CHD, two of bellow ten criteria should be met
Exclusion Criteria:
After corrective procedure for CHD:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xu Zhuo-ming, M.D., PhD. | Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center | Shanghai | 200127 | China |
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| distilled water | Drug | 2 ml per session |
|
|
| D002318 |
| Cardiovascular Diseases |