Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597427
• Other study ID #: UNIFESP-02
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2012
• Last updated: May 10, 2012
• Start date: March 2009
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Clonidine
Administration of 2 µg/kg of intravenous clonidine
• Placebo
Injection of placebo solution.

Locations

Country	Name	City	State
Brazil	Luiz Fernando dos Reis Falcao	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Doses of Dobutamine	Evaluate the need for using and dose of dobutamine immediately after extracorporeal circulation between groups.	During intraoperative (hours)	Yes
Secondary	Doses of Sodium nitroprusside	Evaluate the need for using and dose of sodium nitroprusside immediately after extracorporeal circulation between groups.	During intraoperative (hours)	Yes