NCT01616069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

Same day

First QC Date

April 25, 2012

Last Update Submit

May 29, 2015

Conditions

Cardiopulmonary Bypass Graft

Keywords

CABGEchocardiographyHeart FailureHeart Function

Outcome Measures

Primary Outcomes (1)

  • Systolic and diastolic heart function

    Assessment the systolic and diastolic heart function

    Two years

Secondary Outcomes (1)

  • Mortality after CABAG

    Two years

Study Arms (2)

epinephrine

ACTIVE COMPARATOR

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

Drug: epinephrine and levosimendan

levosimendan

ACTIVE COMPARATOR

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

Drug: epinephrine and levosimendan

Interventions

epinephrine and levosimendanDRUG

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

epinephrinelevosimendan

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology / Ministry of Health

Rio de Janeiro, Rio de Janeiro, 3600-100, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 22480207RESULT

  • 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.

    PMID: 22459932RESULT

  • 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.

    PMID: 22440381RESULT

  • 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.

    PMID: 22004267RESULT

  • 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.

    PMID: 26655803DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

EpinephrineSimendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrazonesHydrazinesPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marcello F Salgado Filho, Master

    National Institute of Cardiology/Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 25, 2012

First Posted

June 11, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

December 1, 2013

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations

BR(1)