Coronary Artery Bypass, Coronary Artery Disease(CAD), Coronary Artery Disease With Need for Bypass Surgery, Hemodynamic Management, Hemodynamic Optimization, Noradrenaline, Off Pump Coronary Artery Bypass Graft, Off Pump Coronary Artery Bypass Surgery
Conditions
Keywords
open-heart coronary bypass, passive leg raising, hemodynamic management, off-pump CABG surgery
Brief summary
This interventional prospective randomized study is designed to compare hemodynamic management using postural mobilization (+/- noradrenaline) versus noradrenaline only in patients undergoing open-heart coronary artery bypass graft (CABG) surgery.
Detailed description
OPTICAB is a single-site study in France that aims to compare two hemodynamic management techniques during off-pump coronary artery bypass graft (CABG) surgery: postural mobilization (+/- noradrenaline) versus noradrenaline only. Primary objective is to evaluate how often noradrenaline is needed when managing hemodynamics using postural mobilization (passive leg raising) during off-pump CABG surgery. The study will also compare revascularization rate and post-operative complications among both groups, and assess perioperative hemodynamic management during the 30-day follow up period.
Interventions
Passive leg raising will be used in the experimental group in order to manage hemodynamics: legs will be raised to an angle of approx. 45°
Noradrenaline will be used for hemodynamic management. Passive leg raising will not be used in this group
Sponsors
Study design
Intervention model description
Single-site, prospective, interventional, single-blind randomized controlled trial
Eligibility
Inclusion criteria
* Adult patient * patient requiring isolated coronary bypass surgery * Elective procedure or medical emergency * First cardiac surgery * Patient with an EF ≥30% * Mandatory affiliation to a social security system * Signed informed consent form * Suspension of renin-angiotensin system inhibitors and angiontensn-neprilysin receptor blockers and sartans the day before surgical procedure
Exclusion criteria
* Contraindication to an inotropic substance (only NA will be used) * Contraindication to passive leg raising * Patient in a life-threatening emergency * History of cardiac surgery * Bilateral iliac or common femoral artery occlusion * EF \< 30% * Pregnancy and breastfeeding * Renal failure (GFR \< 40 ml/min/1.73 m²) * Patient with bilateral thigh amputation * Class III obesity BMI \> 40 kg/m²
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess use of noradrenaline in the experimental group (postural mobilization) vs control group (NA only) for hemodynamic management during open-heart coronary bypass graft surgery. | From beginning to end of urgery |
Countries
France