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

NCT ID: NCT01616069

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Bypass Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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epinephrine

Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE.

Group Type ACTIVE_COMPARATOR

epinephrine and levosimendan

Intervention Type DRUG

epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)

levosimendan

Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE.

Group Type ACTIVE_COMPARATOR

epinephrine and levosimendan

Intervention Type DRUG

epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)

Interventions

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epinephrine and levosimendan

epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role collaborator

National Institute of Cardiology/Ministry of Health

UNKNOWN

Sponsor Role collaborator

Federal University of Juiz de Fora

OTHER

Sponsor Role lead

Responsible Party

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Marcello F Salgado Filho, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcello F Salgado Filho, Master

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology/Ministry of Health

Locations

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National Institute of Cardiology / Ministry of Health

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 22480207 (View on PubMed)

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.

Reference Type RESULT
PMID: 22459932 (View on PubMed)

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.

Reference Type RESULT
PMID: 22440381 (View on PubMed)

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.

Reference Type RESULT
PMID: 22004267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26655803 (View on PubMed)

Related Links

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Other Identifiers

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0362/14-12-2011

Identifier Type: -

Identifier Source: org_study_id

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