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

April 25, 2012
February 22, 2013
February 2012
February 2012   (final data collection date for primary outcome measure)
Systolic and diastolic heart function [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Assessment the systolic and diastolic heart function
Same as current
Complete list of historical versions of study NCT01616069 on ClinicalTrials.gov Archive Site
Mortality after CABAG [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Assessment mortality after CABAG
Same as current
Not Provided
Not Provided
 
Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography
Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiopulmonary Bypass Graft
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: epinephrine
    Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
    Intervention: Drug: epinephrine,dobutamine, milrinone, levosimendan
  • Active Comparator: dobutamine
    Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
    Intervention: Drug: epinephrine,dobutamine, milrinone, levosimendan
  • Active Comparator: milrinone
    Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
    Intervention: Drug: epinephrine,dobutamine, milrinone, levosimendan
  • Active Comparator: levosimendan
    Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine, milrinone, dobutamine and levosimendan using TEE.
    Intervention: Drug: epinephrine,dobutamine, milrinone, levosimendan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No accept
  • Severe valvular regurgitation or stenoses
  • Chest pain
  • Cardiogenic shock
Both
45 Years to 65 Years
No
Contact: Marcello F Salgado, Master 99858833 mfonsecasalgado@hotmail.com
Brazil
 
NCT01616069
0362/14-12-2011
Yes
Marcello F Salgado Filho, MD, Federal University of Rio de Janeiro
Federal University of Juiz de Fora
  • Universidade Federal do Rio de Janeiro
  • National Institute of Cardiology/Ministry of Health
Not Provided
Federal University of Juiz de Fora
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP