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Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616069
First Posted: June 11, 2012
Last Update Posted: June 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universidade Federal do Rio de Janeiro
National Institute of Cardiology/Ministry of Health
Information provided by (Responsible Party):
Marcello F Salgado Filho, MD, Universidade Federal do Rio de Janeiro
  Purpose
This is a double blind randomization study, assessing hemodynamic response in patients who underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan will be assessment.

Condition Intervention Phase
Cardiopulmonary Bypass Graft Drug: epinephrine and levosimendan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography

Resource links provided by NLM:


Further study details as provided by Marcello F Salgado Filho, MD, Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Systolic and diastolic heart function [ Time Frame: Two years ]
    Assessment the systolic and diastolic heart function


Secondary Outcome Measures:
  • Mortality after CABAG [ Time Frame: Two years ]
    Assessment mortality after CABAG


Enrollment: 81
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epinephrine
Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE.
Drug: epinephrine and levosimendan
epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)
Active Comparator: levosimendan
Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE.
Drug: epinephrine and levosimendan
epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sinusal ritmus
  • EF > 35%
  • Elective CABG surgery

Exclusion Criteria:

  • No accept
  • Severe valvular regurgitation or stenoses
  • Chest pain
  • Cardiogenic shock
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616069


Locations
Brazil
National Institute of Cardiology / Ministry of Health
Rio de janeiro, RJ, Brazil, 3600-100
Sponsors and Collaborators
Federal University of Juiz de Fora
Universidade Federal do Rio de Janeiro
National Institute of Cardiology/Ministry of Health
Investigators
Principal Investigator: Marcello F Salgado Filho, Master National Institute of Cardiology/Ministry of Health
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcello F Salgado Filho, MD, Principal investigator, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01616069     History of Changes
Other Study ID Numbers: 0362/14-12-2011
First Submitted: April 25, 2012
First Posted: June 11, 2012
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by Marcello F Salgado Filho, MD, Universidade Federal do Rio de Janeiro:
CABG
Echocardiography
Heart Failure
Heart Function

Additional relevant MeSH terms:
Epinephrine
Racepinephrine
Epinephryl borate
Simendan
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Protective Agents