Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery (OPTICAB)

Infirmerie Protestante de Lyon

Status: Enrolling

Conditions: Noradrenaline; Hemodynamic Management; Hemodynamic Optimization; Coronary Artery Disease With Need for Bypass Surgery; Coronary Artery Bypass; Off Pump Coronary Artery Bypass Graft; Coronary Artery Disease(CAD); Off Pump Coronary Artery Bypass Surgery

Treatments: Procedure: Use of Noradrenaline only in control group; Procedure: passive leg raising for hemodynamic management during open-heart coronary bypass grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT07163858

IPL/01-2024

ID-RCB: 2024-A00683-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline)

Experimental group

Description:

In order to manage hemodynamics, postural mobilization will be applied by raising legs passively up to a 45° angle prior to any drug use (noradrenaline). If passive leg raising is not sufficient, noradrenaline will be used to stabilize hemodynamics,.

Treatment:

Procedure: passive leg raising for hemodynamic management during open-heart coronary bypass grafting

Control group: use of noradrenaline only (no postural mobilization)

Active Comparator group

Description:

Noradrenaline will be used to manage hemodynamics. Passive leg raising will not be used in this group

Treatment:

Procedure: Use of Noradrenaline only in control group