NCT07163858

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Oct 2025Aug 2027

First Submitted

Initial submission to the registry

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

September 1, 2025

Last Update Submit

November 25, 2025

Conditions

Off Pump Coronary Artery Bypass GraftOff Pump Coronary Artery Bypass SurgeryHemodynamic ManagementHemodynamic OptimizationNoradrenalineCoronary Artery Disease With Need for Bypass SurgeryCoronary Artery Disease(CAD)Coronary Artery Bypass

Keywords

open-heart coronary bypasspassive leg raisinghemodynamic managementoff-pump CABG surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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,.

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

Procedure: Use of Noradrenaline only in control group

Interventions

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

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°

Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline)
Use of Noradrenaline only in control groupPROCEDURE

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infirmerie Protestante de Lyon

Caluire-et-Cuire, Auvergne-Rhône-Alpes, 69300, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

SIESS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-site, prospective, interventional, single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 9, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

A plan has not yet been decided

Locations

FR(1)