Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luiz Fernando dos Reis Falcao, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01597427
First received: May 8, 2012
Last updated: May 10, 2012
Last verified: May 2012

May 8, 2012
May 10, 2012
March 2009
April 2011   (final data collection date for primary outcome measure)
Reduction pulmonary artery pressure [ Time Frame: During intraoperative (hours) ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01597427 on ClinicalTrials.gov Archive Site
  • Doses of Dobutamine [ Time Frame: During intraoperative (hours) ] [ Designated as safety issue: Yes ]
    Evaluate the need for using and dose of dobutamine immediately after extracorporeal circulation between groups.
  • Doses of Sodium nitroprusside [ Time Frame: During intraoperative (hours) ] [ Designated as safety issue: Yes ]
    Evaluate the need for using and dose of sodium nitroprusside immediately after extracorporeal circulation between groups.
Same as current
Not Provided
Not Provided
 
Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery
Intravenous Clonidine Does Not Reduce Pulmonary Artery Pressure in Patients Subjected to Cardiac

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Anesthesia
  • Drug: Clonidine
    Administration of 2 μg/kg of intravenous clonidine
  • Drug: Placebo
    Injection of placebo solution.
  • Sham Comparator: Clonidine
    Administration of 2 μg/kg of intravenous clonidine.
    Intervention: Drug: Clonidine
  • Placebo Comparator: Placebo
    Injection of placebo solution.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
March 2012
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01597427
UNIFESP-02
No
Luiz Fernando dos Reis Falcao, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Study Chair: Luiz Fernando R Falcao, Ph.D. Federal University of Sao Paulo
Principal Investigator: Benedito B Joao, MD Federal University of São Paulo
Federal University of São Paulo
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP