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

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07163858
Acronym
OPTICAB
Enrollment
50
Registered
2025-09-09
Start date
2025-10-06
Completion date
2027-08-31
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

open-heart coronary bypass, passive leg raising, hemodynamic management, off-pump CABG surgery

Brief 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.

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.

Interventions

PROCEDUREpassive leg raising for hemodynamic management during open-heart coronary bypass grafting

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°

PROCEDUREUse of Noradrenaline only in control group

Noradrenaline will be used for hemodynamic management. Passive leg raising will not be used in this group

Sponsors

Infirmerie Protestante de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Single-site, prospective, interventional, single-blind randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

France

Contacts

Primary ContactSIESS
recherche-clinique@infirmerie-protestante.com+33 426297927

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026