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

NCT ID: NCT07163858

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-06

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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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

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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 Hemodynamic Optimization Noradrenaline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-site, prospective, interventional, single-blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline)

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,.

Group Type EXPERIMENTAL

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

Intervention Type 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°

Control group: use of noradrenaline only (no postural mobilization)

Noradrenaline will be used to manage hemodynamics. Passive leg raising will not be used in this group

Group Type ACTIVE_COMPARATOR

Use of Noradrenaline only in control group

Intervention Type PROCEDURE

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

Interventions

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passive 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°

Intervention Type PROCEDURE

Use of Noradrenaline only in control group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Infirmerie Protestante de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Infirmerie Protestante de Lyon

Caluire-et-Cuire, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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SIESS

Role: CONTACT

+33 426297927

Other Identifiers

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ID-RCB: 2024-A00683-44

Identifier Type: OTHER

Identifier Source: secondary_id

IPL/01-2024

Identifier Type: -

Identifier Source: org_study_id

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