Cardiopulmonary Bypass GraftPhase 4NCT01616069
Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography
A Phase 4 study testing epinephrine and levosimendan in people with Cardiopulmonary Bypass Graft, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Cardiopulmonary Bypass Graft
- What is being tested?
- epinephrine and levosimendan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sinusal ritmus
- EF > 35%
- Elective CABG surgery
Who cannot join
- No accept
- Severe valvular regurgitation or stenoses
- Chest pain
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country.
Brazil1 site
National Institute of Cardiology / Ministry of Health
Rio de Janeiro, Rio de Janeiro, 3600-100
About this study
Official title: 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.
- Conditions
- Cardiopulmonary Bypass Graft
- Being tested
- epinephrine and levosimendan
- Keywords
- CABG, Echocardiography, Heart Failure, Heart Function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinephrine and levosimendanDrug
epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)
| Study group | Role | What they receive |
|---|---|---|
| epinephrine | Active comparator | Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE. Receives: Drug: epinephrine and levosimendan |
| levosimendan | Active comparator | Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE. Receives: Drug: epinephrine and levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic heart function
Assessment the systolic and diastolic heart function
Measured: Two years
Secondary outcomes (1)
Mortality after CABAG
Assessment mortality after CABAG
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro, National Institute of Cardiology/Ministry of Health
- Responsible party
- Principal investigator, Marcello F Salgado Filho, MD, Universidade Federal do Rio de Janeiro
- Investigators
- Marcello F Salgado Filho, Master, Principal investigator, National Institute of Cardiology/Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616069
- Sponsor's protocol ID
- 0362/14-12-2011
- Status last verified
- May 2015
- First submitted
- 25 Apr 2012
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22480207De 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.
PubMed 22459932Salgado 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.
PubMed 22440381Fattouch 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.
PubMed 22004267Salgado 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.
PubMed 26655803
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography
- ClinicalTrials.gov ID
- NCT01616069
- Acronym / sponsor ID
- 0362/14-12-2011
- Conditions
- Cardiopulmonary Bypass Graft
- Keywords
- CABG, Echocardiography, Heart Failure, Heart Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro, National Institute of Cardiology/Ministry of Health
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epinephrine | Active comparator | Drug: epinephrine and levosimendanAssessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE. |
| levosimendan | Active comparator | Drug: epinephrine and levosimendanAssessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sinusal ritmus
- EF > 35%
- Elective CABG surgery
Key exclusion criteria (4 listed)
- No accept
- Severe valvular regurgitation or stenoses
- Chest pain
- Cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epinephrine and levosimendanepinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min) | Drug | epinephrine, levosimendan |
Primary outcome
Systolic and diastolic heart function
Time frame: Two years
Assessment the systolic and diastolic heart function
1 secondary outcome
Mortality after CABAG
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Results publication: PubMed 22480207Chung 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.
- Results publication: PubMed 22459932De 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.
- Results publication: PubMed 22440381Salgado 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.
- Results publication: PubMed 22004267Fattouch 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.
- Derived from this study: PubMed 26655803Salgado 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.
- Related InfoLink provided by the sponsor.
Related trials for Cardiopulmonary Bypass Graft
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
Recruiting
Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting
Coronary Artery Disease (CAD), Bypass, Cardiopulmonary
Enrolling by invitationPhase 2/3
Colchicine for the Prevention of Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Strategy-Stratified, Randomized, Double-Blind, Placebo-Controlled Trial
Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)
RecruitingPhase 2
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello F Salgado Filho, Master principal investigator
National Institute of Cardiology/Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epinephrine and levosimendan in people with Cardiopulmonary Bypass Graft, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic heart function (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616069, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.