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Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery

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ClinicalTrials.gov Identifier: NCT03517189
Recruitment Status : Unknown
Verified April 2018 by Solange Guizilini, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Solange Guizilini, Federal University of São Paulo

Study Description
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Brief Summary:
Introduction: Aorta no-touch off-pump coronary artery bypass surgery (OPCAB) has been the recommended technique for treatment of patients with high-risk of neurological damage or stroke. However, the displacement of the heart to achieve suitable exposure for graft construction elicits hemodynamic changes, potentially requiring conversion to on-pump. Objective: The aim of this study is to evaluate the sequential changes of hemodynamic parameters in patients that undergo aorta no-touch OPCAB. Method: Patients that undergo aorta no-touch OPCAB will be evaluated. The FloTrac / PreSep / Vigileo ™ (Edwards Lifesciences) system will be used to continuously record heart rate (HR), mean arterial pressure (DBP), central venous pressure (CVP), continuous cardiac index, systolic volume , systolic volume variation (VVS) and central venous oxygen saturation (ScvO2). The parameters will be evaluated 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending PD, marginal-OM and diagonal-Dg). Postoperative lactate will also be evaluated.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Aorta No-touch Procedure: Aorta no-touch Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Aorta no-touch
Aorta no-touch off-pump coronary artery bypass surgery.
 Procedure: Aorta no-touch
Participants will be submitted to aorta no-touch off-pump coronary artery bypass surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Change in heart rate [ Time Frame: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg). ]
    By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in heart rate during procedures

  2. Change in mean arterial blood pressure [ Time Frame: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg). ]
    By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in mean arterial blood pressure during procedures

  3. Change in central venous pressure [ Time Frame: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg). ]
    By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous pressure during procedures

  4. Change in continuous cardiac index [ Time Frame: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg). ]
    By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in continuouns cardiac index during procedures

  5. Change in stroke volume [ Time Frame: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg). ]
    By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in stroke volume during procedures

  6. Change in central venous oxygen saturation [ Time Frame: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg). ]
    By the FloTrac /PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous oxygen saturation during procedures


Secondary Outcome Measures :
  1. Evaluate lactate levels [ Time Frame: Immediate postoperative period, at the admission on the intensive care unit ]
    Evaluation of the lactate levels in the immediate postoperative


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a diagnosis of coronary artery disease with indication of myocardial revascularization surgery

Exclusion Criteria:

  • patients will be excluded if they presented clinically significant preoperative hepatic or renal dysfunction, thrombocytopenia, coagulopathy, or uncontrolled arrhythmia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517189


Locations
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Brazil
Federal University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04023062
Contact: Solange Guizilini, PhD    +5511982887753    s_guizilini@yahoo.com.br   
Principal Investigator: Walter J. Gomes, PhD         
Sponsors and Collaborators
Federal University of São Paulo
More Information
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Responsible Party: Solange Guizilini, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03517189    
Other Study ID Numbers: 63054016.1.0000.5505
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No