Clinical trial NCT01616069: Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography
Official title: Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiopulmonary Bypass Graft
Keywords: CABG
Echocardiography
Heart Failure
Heart Function
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
name: National Institute of Cardiology/Ministry of Health
First posted: 2012-06-11
Enrollment: 81
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Sinusal ritmus
* EF \> 35%
* Elective CABG surgery

Exclusion Criteria:

* No accept
* Severe valvular regurgitation or stenoses
* Chest pain
* Cardiogenic shock

Primary outcomes:
measure: Systolic and diastolic heart function
timeFrame: Two years
Secondary outcomes:
measure: Mortality after CABAG
timeFrame: Two years
Other outcomes:
Locations:
city: Rio de janeiro
country: Brazil
facility: National Institute of Cardiology / Ministry of Health
state: RJ
Study officials:
affiliation: National Institute of Cardiology/Ministry of Health
name: Marcello F Salgado Filho, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung PC, Huang PC, Liu YF, Chen KB. Transesophageal echocardiography, more than a diagnostic tool: use during surgical ligation of coronary artery fistulae - a case report. J Cardiothorac Surg. 2012 Apr 6;7:28. doi: 10.1186/1749-8090-7-28.
citation: De Mey N, Couture P, Laflamme M, Denault AY, Perrault LP, Deschamps A, Rochon AG. Intraoperative changes in regional wall motion: can postoperative coronary artery bypass graft failure be predicted? J Cardiothorac Vasc Anesth. 2012 Jun;26(3):371-5. doi: 10.1053/j.jvca.2012.02.005. Epub 2012 Mar 28.
citation: Salgado Filho MF, Siciliano A, Siciliano A, Oliveira AJ, Salgado J, Palitot I. The importance of transesophageal echocardiography in heart harvesting for cardiac transplantation. Rev Bras Anestesiol. 2012 Mar-Apr;62(2):262-8. doi: 10.1016/S0034-7094(12)70124-1.
citation: Fattouch K, Castrovinci S, Murana G, Novo G, Caccamo G, Bertolino EC, Sampognaro R, Novo S, Ruvolo G, Lancellotti P. Multiplane two-dimensional versus real time three-dimensional transesophageal echocardiography in ischemic mitral regurgitation. Echocardiography. 2011 Nov;28(10):1125-32. doi: 10.1111/j.1540-8175.2011.01528.x. Epub 2011 Oct 17.
citation: Salgado Filho MF, Barral M, Barrucand L, Cavalcanti IL, Vercosa N. A Randomized Blinded Study of the Left Ventricular Myocardial Performance Index Comparing Epinephrine to Levosimendan following Cardiopulmonary Bypass. PLoS One. 2015 Dec 14;10(12):e0143315. doi: 10.1371/journal.pone.0143315. eCollection 2015.