Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Intravenous Clonidine Does Not Reduce Pulmonary Artery Pressure in Patients Subjected to Cardiac

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Clonidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing an informed consent form, Aged 18 to 80 years Pulmonary hypertension due to left heart disease, Physical status 2 or 3 according to the classification system of the American Society of Anesthesiologists, Subjected to cardiac circulation with extracorporeal circulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Clonidine<br>Administration of 2 μg/kg of intravenous clonidine. | Drug: Clonidine<br>* Administration of 2 μg/kg of intravenous clonidine<br>|
| Placebo Comparator: Placebo<br>Injection of placebo solution. | Drug: Placebo<br>* Injection of placebo solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Evaluate the need for using and dose of sodium nitroprusside immediately after extracorporeal circulation between groups. | During intraoperative (hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clonidine, Hypertension Pulmonary, Cardiac Surgical Procedures