Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients

NCT06952907 | Recruiting

• 1 other identifier: 2024/897
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Acute circulatory failure, often presenting as arterial hypotension, is a major contributor to postoperative morbidity and mortality. Accurate blood pressure (BP) monitoring is essential for timely therapeutic intervention, particularly in patients undergoing major surgery. Among invasive BP measurement sites, the radial artery is commonly used due to its accessibility and ease of catheterization. However, physiologically, the radial artery may underestimate central arterial pressure compared to the femoral artery, especially in patients receiving vasopressors or in critical conditions. This discrepancy can lead to overtreatment with vasopressors and associated complications. Current literature on the accuracy of radial versus femoral BP monitoring is outdated and based solely on observational studies. There is a lack of high-quality randomized data to inform clinical guidelines. Hypothesis: Femoral arterial pressure monitoring, by offering more accurate hemodynamic data, reduces the need for vasopressor support, particularly norepinephrine, compared to radial artery monitoring. Primary Objective: To compare the effect of femoral versus radial invasive BP monitoring on the proportion of patients requiring norepinephrine from anesthetic induction to postoperative day 7 (D7) following elective cardiac surgery. Norepinephrine treatment is defined by continuous intravenous administration of norepinephrine for more than 1 minute. Secondary Objectives : To compare the following outcomes between the two strategies within the first 7 postoperative days: incidence of acute kidney injury (AKI) according to KDIGO criteria, incidence of cardiac complications (arrhythmias requiring treatment, myocardial injury (troponin \>99th percentile or \>20% rise from baseline), myocardial infarction, cardiogenic shock, cardiac arrest), vaso-inotropic score (VIS), duration of any vasopressor therapy (days), ICU and hospital length of stay (days), all-cause mortality at day 7 and day 30, total duration (hours/days) and maximal dose of norepineprhine therapy, intraoperative hypotension episodes (MAP\<65 mmHg \> 5 min), incidence of arterial catheter-related complications (hematoma, bleeding, infection, thrombosis, arterial occlusion, malfunction, dislodgement). Primary Endpoint: The proportion of patients receiving continuous intravenous norepinephrine from anesthesia induction to postoperative day 7. Secondary Endpoints: AKI occurrence or need for renal replacement therapy; cardiac complications: atrial/ventricular arrhythmias requirinf treatment, myocardial injury (troponin \>99th percentile or \>20% rise from baseline), myocardial infarction (biomarker elevation + ECG or echocardiographic abnormalities), cardiogenic shock, cardiac arrest; maximum VIS in the OR, ICU admission, and day 1; intraoperative hypotension episodes (MAP\<65 mmHg \> 5 min); total norepinephrine support duration (in hours); duration of any vasopressor therapy; arterial line complications: malfunction, dislodgement, hematoma, thrombosis, infection, bleeding, arterial occlusion; ICU and hospital length of stay (days); all-cause mortality at day 7 and day 30 Study Design: A prospective, multicenter (Besançon and Dijon University Hospitals), randomized, superiority, single-blind, intention-to-treat clinical trial in adults undergoing elective cardiac surgery. Patients are randomized to femoral or radial artery catheterization for continuous BP monitoring. Sample Size: Based on an expected norepinephrine use rate of 70%, a 15% absolute risk reduction, α = 0.05, and power = 90%, 162 patients per group are required. Accounting for 5% data loss, 340 patients will be enrolled. Study Arms: Radial group: invasive BP monitoring via radial artery catheterization Femoral group: invasive BP monitoring via femoral artery catheterization The arterial line is placed under ultrasound guidance in the operating room and maintained postoperatively in the ICU or critical care unit until no longer clinically indicated. Eligibility Criteria Inclusion: adults patients ≥18 years undergoing elective on-pump cardiac surgery with informed consent. Exclusion: emergency surgery, use of dual arterial lines, heart transplantation, mechanical circulatory support, contraindications to radial/femoral catheterization, legal or ethical inability to consent. Study Timeline Inclusion period: 36 months Patient follow-up: 7 days post-surgery Total study duration: 36 months Data Collection: Clinical data are collected by research staff using an electronic case report form (e-CRF) via CleanWeb™ software. Expected Impact: There are currently no guidelines specifying the optimal site for invasive BP monitoring. This study aims to provide robust evidence on whether femoral BP monitoring improves clinical outcomes, reduces vasopressor use, and minimizes adverse events. Positive findings could inform future practice guidelines and lead to broader investigations in other clinical settings.

Conditions

Vasoplegia Syndrome; Vasoplegia; Cardiac Surgical Procedures; Arterial Pressure; Hypotension During Surgery; Hypotension Postprocedural; Norepinephrine

Keywords

Invasive arterial blood pressure monitoring; Vasoplegia syndrome; Cardiac surgery; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• Number of patients treated with continuous intravenous norepinephrine

  Number of patients treated with continuous intravenous norepinephrine to treat arterial hypotension related to vasoplegic syndrome from the time of anesthetic induction until postoperative day 7. Norepinephrine treatment is defined by continuous intravenous administration of norepinephrine for more than 1 minute.

  Within 7 days after surgery

Secondary Outcomes (13)

• Rate of renal complications

  Within 7 days after surgery

• Rate of cardiac complications

  Within 7 days after surgery

• Maximum vasoactive-inotropic score (VIS)

  Intraoperatively, during the surgery, from surgical incision to end of surgery, in the operating room

• Vasoactive-inotropic score (VIS) value

  At admission in the postoperative intensive care unit (ICU) (up to 2 hours after surgery)

• Maximum vasoactive-inotropic score (VIS) value

  Within 1 day after surgery

Study Arms (2)

Femoral group

ACTIVE COMPARATOR

Patients in the femoral group undergo femoral artery catheterization for continuous invasive arterial blood pressure monitoring.

Other: Femoral artery catheterization for continuous invasive arterial blood pressure monitoring

Radial group

ACTIVE COMPARATOR

Patients in the arterial group undergo arterial artery catheterization for continuous invasive arterial blood pressure monitoring.

Other: Radial artery catheterization for continuous invasive arterial blood pressure monitoring

Interventions

Femoral artery catheterization for continuous invasive arterial blood pressure monitoring OTHER

Femoral artery catheterization allow for continuous invasive arterial blood pressure monitoring.

Femoral group

Radial artery catheterization for continuous invasive arterial blood pressure monitoring OTHER

Radial artery catheterization allows for continuous invasive arterial blood pressure monitoring

Radial group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ≥18 years
• Scheduled cardiac surgery with cardiopulmonary bypass (time between anesthesia consultation and surgery \> 48 hours)
• ASA physical status ≥II
• Affiliation with or beneficiary of the French national health insurance system
• Signed informed consent indicating that the participant has understood the purpose and procedures of the study and agrees to participate and comply with its requirements and restrictions

You may not qualify if:

• Emergency surgery (before the next working day after decision to operate)
• Surgery requiring the use of two arterial pressure monitoring sites: e.g., aortic arch surgery, aortic dissection, etc.
• Heart transplantation surgery
• Mechanical circulatory support
• Contraindication to radial artery catheterization: failed Allen test, Raynaud syndrome, Buerger disease, major hyperlipidemia
• Contraindication to femoral artery catheterization: puncture of vascular prosthetic material in the femoral area (e.g., femoral bypass, femoral stenting, femoral trifurcation endarterectomy, femoral angioplasty)
• Pregnant or breastfeeding women
• Persons deprived of liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a healthcare or social institution for reasons other than research
• Adults under legal protection measures (guardianship, trusteeship, or legal safeguard) or unable to give informed consent

Sponsors & Collaborators

• Guillaume BESCH: lead

Study Sites (2)

Centre Hospitalier Universitaire de Besançon

Besançon, F-25000, France

RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, F-21000, France

RECRUITING

Related Publications (1)

• Guinot PG, Bronnert R, Grelet T, Bouhemad B, Nguyen M, Besch G; FERARI study group. Femoral versus radial arterial pressure monitoring in cardiac surgery patients: protocol for a randomised controlled multicentric superiority trial (FERARI). BMJ Open. 2026 Jan 28;16(1):e111663. doi: 10.1136/bmjopen-2025-111663.

  PMID: 41605595 DERIVED

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume Besch, M.D., Ph.D.

  Centre Hospitalier Universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+333 812 189 58; gbesch@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology and Intensive Care Medicine

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 1, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)