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The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.
Prospective, clinical-interventionist, randomized, and double-blind study. Patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine | Sham Comparator | Administration of 2 μg/kg of intravenous clonidine. |
|
| Placebo | Placebo Comparator | Injection of placebo solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | Administration of 2 μg/kg of intravenous clonidine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction pulmonary artery pressure | Assessed four times: before (T0) administration of 2 μg·kg-1 of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after ECC (T2), and 10 minutes after the injection of protamine (T3). | During intraoperative (hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Doses of Dobutamine | Evaluate the need for using and dose of dobutamine immediately after extracorporeal circulation between groups. | During intraoperative (hours) |
| Doses of Sodium nitroprusside |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luiz Fernando R Falcao, Ph.D. | Federal University of São Paulo | Study Chair |
| Benedito B Joao, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luiz Fernando dos Reis Falcao | São Paulo | São Paulo | 04024-002 | Brazil |
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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 |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo |
| Drug |
Injection of placebo solution. |
|
Evaluate the need for using and dose of sodium nitroprusside immediately after extracorporeal circulation between groups.
| During intraoperative (hours) |
| D002318 |
| Cardiovascular Diseases |
| D006571 |
| Heterocyclic Compounds |