Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Anesthesia

Treatments: Drug: Placebo; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01597427

UNIFESP-02

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups, including a placebo group

Clonidine

Sham Comparator group

Description:

Administration of 2 μg/kg of intravenous clonidine.

Treatment:

Drug: Clonidine

Placebo

Placebo Comparator group

Description:

Injection of placebo solution.

Treatment:

Drug: Placebo