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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.
Led by Infirmerie Protestante de Lyon · Updated on 2025-12-03
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods of managing blood flow during off-pump coronary artery bypass graft (CABG) surgery in adults with coronary artery disease. The study compares postural mobilization, specifically passive leg raising, with the use of noradrenaline alone. The goal is to determine how often noradrenaline is needed when using postural mobilization and to compare surgical outcomes and complications between the two groups. The study involves two groups: one where patients receive postural mobilization by raising their legs to about a 45° angle before any noradrenaline is given, and a control group where only noradrenaline is used to manage blood flow without leg raising. Postural mobilization is applied to help stabilize hemodynamics, and noradrenaline is used if needed. This intervention occurs during the heart surgery itself. Participants will be monitored during surgery and followed for 30 days afterward to assess how hemodynamics were managed, the rate of revascularization, and any post-operative complications. Researchers will measure the use of noradrenaline from the start to the end of surgery and observe patient outcomes during the follow-up period. The total participation includes the surgery day and 30 days post-surgery monitoring.
CONDITIONS
Brief Title
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient
- Patient requiring isolated coronary bypass surgery
- Elective procedure or medical emergency
- First cardiac surgery
- Patient with an ejection fraction (EF) 30%
- Mandatory affiliation to a social security system
- Signed informed consent form
- Suspension of renin-angiotensin system inhibitors, angiotensin-neprilysin receptor blockers and sartans the day before surgical procedure
You will not qualify if you...
- Contraindication to an inotropic substance (only noradrenaline 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
- Ejection fraction (EF) < 30%
- Pregnancy and breastfeeding
- Renal failure (glomerular filtration rate < 40 ml/min/1.73 m8)
- Patient with bilateral thigh amputation
- Class III obesity (BMI > 40 kg/m8)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of surgery and immediate post-operative period
Participants undergo off-pump coronary artery bypass graft surgery with hemodynamic management using either postural mobilization (passive leg raising) with optional noradrenaline or noradrenaline only. This stage includes the active surgery and immediate recovery period.
1 surgery visit and immediate post-operative monitoring
Duration - 30 days after surgery
Participants are monitored for hemodynamic stability, revascularization outcomes, and potential post-operative complications during recovery.
Regular follow-up visits during the 30-day post-operative period
Trial Site Locations
Total: 1 location
1
Infirmerie Protestante de Lyon
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France, 69300
Actively Recruiting
Research Team
S
SIESS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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