Cardiopulmonary Bypass Graft Clinical Trial
Official title:
Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography
| Verified date | May 2015 |
| Source | Federal University of Juiz de Fora |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 81 |
| Est. completion date | December 2013 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Sinusal ritmus - EF > 35% - Elective CABG surgery Exclusion Criteria: - No accept - Severe valvular regurgitation or stenoses - Chest pain - Cardiogenic shock |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | National Institute of Cardiology / Ministry of Health | Rio de janeiro | RJ |
| Lead Sponsor | Collaborator |
|---|---|
| Federal University of Juiz de Fora | National Institute of Cardiology/Ministry of Health, Universidade Federal do Rio de Janeiro |
Brazil,
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. — View 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: 1 — View 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. Echocardi — View 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)70 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Systolic and diastolic heart function | Assessment the systolic and diastolic heart function | Two years | Yes |
| Secondary | Mortality after CABAG | Assessment mortality after CABAG | Two years | Yes |