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The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.
PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remodulin Injection | Experimental | Drug: Remodulin Injection Dosage:5 ng/kg/min-80ng/kg/min(0.15ml/hr-2.4ml/hr) Frequency: intravenous maintenance increase at a rate of 10ng/kg/min (0.3ml/hr)every 30 minutes Durations:48 hours |
|
| Distilled water group | Placebo Comparator | Drug:distilled water Dosage:0.15ml/hr-2.4ml/hr Frequency:increase at a rate of 0.3ml/hr every 30 minutes Durations:48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remodulin | Drug | After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary end point is a composite variable | consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance | the first 48 hours after Remodulin used |
| Measure | Description | Time Frame |
|---|---|---|
| Change from base line of pulmonary hemodynamic measurements | Pp/Ps reduce >10% or TPG≤6mmHg. | baseline and 48 hours |
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Inclusion Criteria:
After Fontan procedure, the criteria should be met
Exclusion Criteria:
After Fontan surgery :
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| Name | Affiliation | Role |
|---|---|---|
| Zhuoming Xu, M.D.,Ph,D. | Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34430604 | Derived | Chen X, Cai XM, Zhang MJ, Xu JH, Li H, Xu ZM. Pharmacokinetics of treprostinil in children with functional single-ventricle pulmonary arterial hypertension: a randomized controlled trial. Ann Transl Med. 2021 Jul;9(14):1163. doi: 10.21037/atm-21-3188. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2023 | |
| Reset | May 10, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2023 | May 10, 2023 |
| 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 |
|---|---|
| C427248 | treprostinil |
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| distilled water | Drug | After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr. |
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| D002318 |
| Cardiovascular Diseases |