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| Name | Class |
|---|---|
| Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery | UNKNOWN |
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This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.
Primary objectives:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iloprost | Experimental | Iloprost nebuliser solution 500 ng/kg inhaled |
|
| distilled water | Placebo Comparator | aerosolized distilled water 1-2 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iloprost nebuliser solution | Drug | Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total incidence of RPH, PHC or death | The primary effective endpoints are reached when any individual components of the primary composite endpoint occur:
| within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from base line of pulmonary hemodynamic measurements |
| within 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhuomin Xu, PhD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Children's Hospital | Guangzhou | Guangdong | 510000 | China | ||
| Wuhan Asia Hear Hospital |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| distilled water | Drug | 1-2 ml aerosolized distilled water inhalation per session |
|
|
| Wuhan |
| Hubei |
| 430022 |
| China |
| Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center | Shanghai | 200127 | China |
| D002318 |
| Cardiovascular Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |