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Completed

NCT Number: NCT01597427

Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

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.

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Key information

Conditions

Anesthesia Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Luiz Fernando dos Reis Falcao

São Paulo, 04024-002, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonidine

Drug

Administration of 2 μg/kg of intravenous clonidine

Placebo

Drug

Injection of placebo solution.

Primary outcomes

  1. Reduction pulmonary artery pressure

    Time frame: During intraoperative (hours)

    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 outcomes

  1. Doses of Dobutamine

    Time frame: During intraoperative (hours)

    Evaluate the need for using and dose of dobutamine immediately after extracorporeal circulation between groups.

  2. Doses of Sodium nitroprusside

    Time frame: During intraoperative (hours)

    Evaluate the need for using and dose of sodium nitroprusside immediately after extracorporeal circulation between groups.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 14, 2012
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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