Coronary Artery Disease With Need for Bypass SurgeryOPTICABNCT07163858
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
A study testing passive leg raising for hemodynamic management during open-heart coronary bypass grafting in people with Coronary Artery Disease With Need for Bypass Surgery and Coronary Artery Disease(CAD), run by Infirmerie Protestante de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD), Coronary Artery Bypass
- What is being tested?
- passive leg raising for hemodynamic management during open-heart coronary bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Infirmerie Protestante de Lyon
Caluire-et-Cuire, Auvergne-Rhône-Alpes, 69300
About this study
Official title: 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 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.
Read the detailed 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.
- Conditions
- Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD), Coronary Artery Bypass, Off Pump Coronary Artery Bypass Graft, Off Pump Coronary Artery Bypass Surgery, Hemodynamic Management
- Being tested
- passive leg raising for hemodynamic management during open-heart coronary bypass grafting, Use of Noradrenaline only in control group
- Keywords
- open-heart coronary bypass, passive leg raising, hemodynamic management, off-pump CABG surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raising for hemodynamic management during open-heart coronary bypass graftingProcedure or surgery
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°
Use of Noradrenaline only in control groupProcedure or surgery
Noradrenaline will be used for hemodynamic management. Passive leg raising will not be used in this group
| Study group | Role | What they receive |
|---|---|---|
| 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,. Receives: Procedure: passive leg raising for hemodynamic management during open-heart coronary bypass grafting |
| 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 Receives: Procedure: Use of Noradrenaline only in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From beginning to end of urgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start6 Oct 2025
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease With Need for Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-site, prospective, interventional, single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infirmerie Protestante de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163858
- Sponsor's protocol ID
- IPL/01-2024
- Other IDs
- ID-RCB: 2024-A00683-44
- Acronym
- OPTICAB
- Status last verified
- Nov 2025
- First submitted
- 1 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A plan has not yet been decided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07163858
- Acronym / sponsor ID
- OPTICAB / IPL/01-2024
- Conditions
- Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD), Coronary Artery Bypass, Off Pump Coronary Artery Bypass Graft, Off Pump Coronary Artery Bypass Surgery, Hemodynamic Management
- Keywords
- open-heart coronary bypass, passive leg raising, hemodynamic management, off-pump CABG surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Infirmerie Protestante de LyonUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-site, prospective, interventional, single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline) | Experimental | Procedure: passive leg raising for hemodynamic management during open-heart coronary bypass graftingIn 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,. |
| Control group: use of noradrenaline only (no postural mobilization) | Active comparator | Procedure: Use of Noradrenaline only in control groupNoradrenaline will be used to manage hemodynamics. Passive leg raising will not be used in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patient
- patient requiring isolated coronary bypass surgery
- Elective procedure or medical emergency
- First cardiac surgery
- Patient with an EF ≥30%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive leg raising for hemodynamic management during open-heart coronary bypass graftingPassive leg raising will be used in the experimental group in order to manage hemodynamics: legs will be raised to an angle of approx. 45° | Procedure or surgery | Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline) |
| Use of Noradrenaline only in control groupNoradrenaline will be used for hemodynamic management. Passive leg raising will not be used in this group | Procedure or surgery | Control group: use of noradrenaline only (no postural mobilization) |
Primary outcome
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.
Time frame: From beginning to end of urgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No. A plan has not yet been decided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive leg raising for hemodynamic management during open-heart coronary bypass grafting in people with Coronary Artery Disease With Need for Bypass Surgery and Coronary Artery Disease(CAD), run by Infirmerie Protestante de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SIESS (+33 426297927, recherche-clinique@infirmerie-protestante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From beginning to end of urgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.