Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06952907

Femoral Versus Radial Artery Catheterization for Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients: the FERARI Randomized Superiority Study

Led by Guillaume BESCH · Updated on 2025-12-22

340

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on adults undergoing elective cardiac surgery with cardiopulmonary bypass. It compares two methods of invasive blood pressure monitoring—femoral artery versus radial artery catheterization—to see if femoral monitoring reduces the need for norepinephrine, a vasopressor, from anesthesia induction until seven days after surgery. The study addresses concerns that radial artery measurements may underestimate central arterial pressure, potentially leading to overtreatment and complications such as acute kidney injury and cardiac events. Current evidence is mainly observational and outdated, so this study aims to provide high-quality randomized data to guide clinical practices. Participants are randomly assigned to one of two groups: one receiving femoral artery catheterization and the other radial artery catheterization for continuous invasive blood pressure monitoring. The catheter is placed under ultrasound guidance in the operating room and remains in place postoperatively in the ICU until no longer needed. The study tracks patients from surgery through postoperative day seven to evaluate various outcomes related to vasopressor use, kidney and heart complications, arterial catheter-related issues, and length of hospital stay. Throughout the study, researchers collect clinical data using electronic forms. They monitor norepinephrine use, episodes of low blood pressure during surgery, cardiac complications like arrhythmias and myocardial injury, kidney injury, and complications related to arterial catheters. Secondary outcomes include vasoactive-inotropic scores, duration and dose of vasopressor therapy, ICU and hospital stays, and mortality at seven and thirty days. The total participation lasts through the first week after surgery, aiming to clarify whether femoral artery monitoring improves patient outcomes and reduces drug use compared to radial artery monitoring.

CONDITIONS

Brief Title

Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 years or older
  • Scheduled for elective cardiac surgery with cardiopulmonary bypass
  • ASA physical status of II or higher
  • Affiliated with or beneficiary of the French national health insurance system
  • Signed informed consent indicating understanding of the study and agreement to participate
Not Eligible

You will not qualify if you...

  • Emergency surgery before the next working day after decision to operate
  • Surgery requiring two arterial pressure monitoring sites (e.g., aortic arch surgery)
  • Heart transplantation surgery
  • Mechanical circulatory support
  • Contraindications to radial artery catheterization such as failed Allen test, Raynaud syndrome, Buerger disease, or major hyperlipidemia
  • Contraindications to femoral artery catheterization including vascular prosthetic material in the femoral area
  • Pregnant or breastfeeding women
  • Persons deprived of liberty by judicial or administrative decision or under compulsory psychiatric care
  • Adults under legal protection measures or unable to give informed consent
  • Currently under exclusion period of another clinical trial or listed in the national registry of research volunteers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants undergo either femoral or radial artery catheterization for continuous invasive arterial blood pressure monitoring during cardiac surgery.

1 visit (in-person, during surgery)

Post-operative Follow-up

Duration - Up to 7 days after surgery

Participants are monitored for up to 7 days after surgery for vasopressor use, renal and cardiac complications, and catheter-related complications.

Daily visits or assessments for up to 7 days

Follow-up

Duration - Up to 30 days after surgery

Participants’ recovery is monitored including ICU and hospital length of stay and mortality up to 30 days after surgery.

Assessments as needed during ICU and hospital stay

Trial Site Locations

Total: 2 locations

1

Centre Hospitalier Universitaire de Besançon

Besançon, France, F-25000

Actively Recruiting

2

Centre Hospitalier Universitaire de Dijon

Dijon, France, F-21000

Actively Recruiting

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Research Team

G

Guillaume Besch, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Femoral versus radial arterial pressure monitoring in cardiac surgery patients: protocol for a randomised controlled multicentric superiority trial (FERARI).

Pierre-Grégoire Guinot, Romain Bronnert, Tommy Grelet...

https://pubmed.ncbi.nlm.nih.gov/41605595