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

April 25, 2012
May 29, 2015
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 and levosimendan
epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)
  • Active Comparator: epinephrine
    Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE.
    Intervention: Drug: epinephrine and levosimendan
  • Active Comparator: levosimendan
    Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE.
    Intervention: Drug: epinephrine and levosimendan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
December 2013
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 information is only displayed when the study is recruiting subjects
Brazil
 
NCT01616069
0362/14-12-2011
Yes
Marcello F Salgado Filho, MD, Universidade Federal do Rio de Janeiro
Federal University of Juiz de Fora
  • Universidade Federal do Rio de Janeiro
  • National Institute of Cardiology/Ministry of Health
Principal Investigator: Marcello F Salgado Filho, Master National Institute of Cardiology/Ministry of Health
Federal University of Juiz de Fora
May 2015

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