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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Federal University of Juiz de Fora
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, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01616069
First received: April 25, 2012
Last updated: February 22, 2013
Last verified: February 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Universidade Federal do Rio de Janeiro
National Institute of Cardiology/Ministry of Health
  More Information

Additional Information:
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:
Dobutamine
Epinephrine
Epinephryl borate
Milrinone
Racepinephrine
Simendan
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 23, 2014