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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB: 2024-A00683-44 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline) | Experimental | 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,. |
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| Control group: use of noradrenaline only (no postural mobilization) | Active Comparator | Noradrenaline will be used to manage hemodynamics. Passive leg raising will not be used in this group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| passive leg raising for hemodynamic management during open-heart coronary bypass grafting | Procedure | 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° |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SIESS | Contact | +33 426297927 | recherche-clinique@infirmerie-protestante.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infirmerie Protestante de Lyon | Recruiting | Caluire-et-Cuire | Auvergne-Rhône-Alpes | 69300 | France |
A plan has not yet been decided
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Single-site, prospective, interventional, single-blind randomized controlled trial
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| Use of Noradrenaline only in control group | Procedure | Noradrenaline will be used for hemodynamic management. Passive leg raising will not be used in this group |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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