Comparison of Hemodynamic Management by Postural Mobilization Versus Chemical Vasoconstriction Using Noradrenaline Exclusively in Off-pump Coronary Artery Bypass Graft Surgery: A Prospective, Randomized, Comparative, Single-center Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: From beginning to end of urgery
次要结局
未报告次要终点