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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Anesthesia
 Drug: Clonidine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Clonidine Does Not Reduce Pulmonary Artery Pressure in Patients Subjected to Cardiac

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 29
Study Start Date: March 2009
Study Completion Date: March 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Clonidine
Administration of 2 μg/kg of intravenous clonidine.
 Drug: Clonidine
Administration of 2 μg/kg of intravenous clonidine
Placebo Comparator: Placebo
Injection of placebo solution.
 Drug: Placebo
Injection of placebo solution.

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597427

Locations
Brazil
Luiz Fernando dos Reis Falcao
Sao Paulo, SP, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Luiz Fernando R Falcao, Ph.D. Federal University of Sao Paulo
Principal Investigator: Benedito B Joao, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Luiz Fernando dos Reis Falcao, Clinical Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01597427     History of Changes
Other Study ID Numbers: UNIFESP-02
Study First Received: May 8, 2012
Last Updated: May 10, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Clonidine
Hypertension Pulmonary
Cardiac Surgical Procedures

Additional relevant MeSH terms:
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013