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

This study is currently recruiting participants.
Verified February 2013 by Federal University of Juiz de Fora
Sponsor:
Collaborators:
Federal University of Rio de Janeiro
National Institute of Cardiology/Ministry of Health
Information provided by (Responsible Party):
Marcello F Salgado Filho, MD, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01616069
First received: April 25, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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,dobutamine, milrinone, levosimendan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:

U.S. FDA Resources

Further study details as provided by Federal University of Juiz de Fora:

Primary Outcome Measures:
  • Systolic and diastolic heart function [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Assessment the systolic and diastolic heart function


Secondary Outcome Measures:
  • Mortality after CABAG [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Assessment mortality after CABAG


Estimated Enrollment: 120
Study Start Date: February 2012
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 epinephrine, milrinone, dobutamine and levosimendan using TEE.
 Drug: epinephrine,dobutamine, milrinone, levosimendan
epinephrine (0,06mcg/kg/min), dobutamine (10 mcg/kg/min), mirinone (0,5 mcg/kg/min), levosimendan (0,2 mcg/kg/min)
Active Comparator: dobutamine
Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
 Drug: epinephrine,dobutamine, milrinone, levosimendan
epinephrine (0,06mcg/kg/min), dobutamine (10 mcg/kg/min), mirinone (0,5 mcg/kg/min), levosimendan (0,2 mcg/kg/min)
Active Comparator: milrinone
Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
 Drug: epinephrine,dobutamine, milrinone, levosimendan
epinephrine (0,06mcg/kg/min), dobutamine (10 mcg/kg/min), mirinone (0,5 mcg/kg/min), levosimendan (0,2 mcg/kg/min)
Active Comparator: levosimendan
Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
 Drug: epinephrine,dobutamine, milrinone, levosimendan
epinephrine (0,06mcg/kg/min), dobutamine (10 mcg/kg/min), mirinone (0,5 mcg/kg/min), levosimendan (0,2 mcg/kg/min)

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616069

Contacts
Contact: Marcello F Salgado, Master 99858833 mfonsecasalgado@hotmail.com

Locations
Brazil
National Institute of Cardiology / Ministry of Health Recruiting
Rio de janeiro, RJ, Brazil, 3600-100
Contact: Marcello F Salgado Filho, Master     99858833     mfonsecasalgado@hotmail.com    
Principal Investigator: Marcello F Salgado Filho, Master            
Sponsors and Collaborators
Federal University of Juiz de Fora
Federal University of Rio de Janeiro
National Institute of Cardiology/Ministry of Health
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Marcello F Salgado Filho, MD, Principal investigator, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01616069     History of Changes
Other Study ID Numbers: 0362/14-12-2011
Study First Received: April 25, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Federal University of Juiz de Fora:
CABG
Echocardiography
Heart Failure
Heart Function

Additional relevant MeSH terms:
Epinephrine
Dobutamine
Epinephryl borate
Milrinone
Simendan
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Cardiotonic Agents
Adrenergic beta-1 Receptor Agonists
Protective Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013