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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01616069
First received: April 25, 2012
Last updated: May 29, 2015
Last verified: May 2015
  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
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:


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


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: April 25, 2012
Last Updated: May 29, 2015
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
Epinephryl borate
Racepinephrine
Simendan
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 30, 2015