Postural mobilization versus noradrenaline during off-pump coronary bypass
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.
This will test whether using passive leg‑raising with or without noradrenaline reduces the need for noradrenaline in adults having off‑pump coronary artery bypass surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Infirmerie Protestante de Lyon Academic / other |
| Locations | 1 site (Caluire-et-Cuire, Auvergne-Rhône-Alpes) |
| Trial ID | NCT07163858 on ClinicalTrials.gov |
What this trial studies
OPTICAB is a single-center randomized trial in Lyon comparing two hemodynamic management strategies during off‑pump coronary artery bypass grafting: postural mobilization (passive leg raising) with supplemental noradrenaline as needed versus noradrenaline alone. Patients are randomized intraoperatively and followed for 30 days to record vasopressor use, revascularization rates, and postoperative complications. The primary outcome is how often noradrenaline is required when passive leg raising is used as part of hemodynamic management. Secondary outcomes include perioperative hemodynamic parameters and postoperative clinical events over the 30‑day follow‑up.
Who should consider this trial
Good fit: Adults undergoing isolated off‑pump coronary artery bypass grafting with left ventricular ejection fraction ≥30% who can provide informed consent are ideal candidates.
Not a fit: Patients with EF <30%, contraindications to passive leg raising, bilateral iliac or common femoral artery occlusion, severe renal failure (GFR <40), class III obesity (BMI >40), pregnancy, or bilateral thigh amputation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce reliance on vasopressors and their side effects, potentially improving recovery after off‑pump CABG.
How similar studies have performed: Passive leg raising is a well‑validated way to predict fluid responsiveness in critical care, but using it as the main intraoperative hemodynamic management strategy during off‑pump CABG is novel and not widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caluire-et-Cuire, Auvergne-Rhône-Alpes
- Infirmerie Protestante de Lyon — Caluire-et-Cuire, Auvergne-Rhône-Alpes, France (Recruiting)
Study contacts
- Study coordinator: Siess
- Email: recherche-clinique@infirmerie-protestante.com
- Phone: +33 426297927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.