Clinical trial NCT03517189: Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery
Official title: Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Aorta No-touch
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in heart rate
timeFrame: 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).
measure: Change in mean arterial blood pressure
timeFrame: 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).
measure: Change in central venous pressure
timeFrame: 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).
measure: Change in continuous cardiac index
timeFrame: 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).
measure: Change in stroke volume
timeFrame: 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).
measure: Change in central venous oxygen saturation
timeFrame: 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).
Secondary outcomes:
measure: Evaluate lactate levels
timeFrame: Immediate postoperative period, at the admission on the intensive care unit
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
References: