Vasoplegia SyndromeFERARINCT06952907
Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients
A study testing Femoral artery catheterization for continuous invasive arterial blood pressure monitoring and Radial artery catheterization for continuous invasive arterial blood pressure monitoring in people with Vasoplegia Syndrome and Vasoplegia, run by Guillaume BESCH at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia Syndrome, Vasoplegia, Cardiac Surgical Procedures
- What is being tested?
- Femoral artery catheterization for continuous invasive arterial blood pressure monitoring and Radial artery catheterization for continuous invasive arterial blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
- Subjects currently under exclusion period of another clinical trial or listed in the national registry of research volunteers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, F-25000
Guillaume Besch, M.D., Ph.D., +333 812 189 58, gbesch@chu-besancon.fr
CHU Besançon
- Recruiting
Centre Hospitalier Universitaire de Dijon
Dijon, F-21000
Pierre Grégoire Guinot, M.D., Ph.D., +333 802 935 28, guinotpierregregoire@gmail.com
About this study
Official title: Femoral Versus Radial Artery Catheterization for Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients: the FERARI Randomized Superiority Study
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.
Read more
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.
Read the detailed description
Acute circulatory failure or shock-typically characterized by arterial hypotension-is a major cause of ICU admission and a significant contributor to postoperative complications in surgery. This condition may result from various pathophysiological mechanisms such as arterial vasodilation, hypovolemia, or low cardiac output, frequently triggered by sepsis, inflammation, surgery, or hemorrhage. Hypotension leads to hypoperfusion of vital organs (kidney, brain, heart), significantly increasing patient morbidity and mortality. Consequently, numerous studies have focused on identifying critical blood pressure thresholds and optimizing therapeutic strategies to reduce associated organ dysfunction and mortality.
A key challenge in the management of hypotension is the accuracy of blood pressure (BP) measurement. In clinical practice, invasive arterial pressure is commonly monitored at radial, brachial, or femoral sites. The radial artery is often preferred for its accessibility and ease of catheterization. However, from a physiological standpoint, the radial artery's small diameter and peripheral location can result in discrepancies when compared to central aortic pressure-the actual pressure driving organ perfusion.
Several studies have shown that in states of shock or acute circulatory failure, radial artery pressure measurements often underestimate actual blood pressure compared to more central measurements such as femoral artery pressure. This difference is particularly pronounced in specific physiological and pathological conditions-e.g., during vasoconstrictor use-where systolic pressure gradients between radial and femoral sites may be significant.
As such, accurate blood pressure monitoring is critical in anesthesia and critical care to guide fluid resuscitation, vasopressor therapy, and interpretation of hemodynamic monitoring tools. Inaccurate measurements may lead to excessive exposure to hypotension or unnecessary administration of vasopressors, both of which carry associated risks.
Scientific literature comparing radial and femoral arterial BP monitoring is limited, outdated (mainly from the 1990s), and largely based on observational data. It is well-established that radial artery monitoring can lead to spuriously low BP readings, resulting in inappropriate hemodynamic management, including excessive fluid resuscitation or vasopressor administration.
Observational studies consistently report the following findings:
A systematic pressure gradient (at least 5-10 mmHg in mean arterial pressure) between femoral and radial sites.
The radial site underestimates femoral BP, and thus organ perfusion pressure. This gradient is more pronounced in critically ill patients, particularly those receiving vasopressors, women, or those with severe illness (e.g., refractory shock, sepsis).
These discrepancies in BP measurement are associated with overuse of hemodynamic drugs. Previous studies reported that over one-third of patients had a significant BP gradient between radial and femoral sites-often leading to excessive vasopressor administration. Other works further support this, indicating higher rates of adverse events, including acute kidney injury (AKI), and excessive vasopressor use in patients monitored at the radial site versus the femoral site.
AKI, frequently observed during shock or in surgical patients, is a key concern. In its severe form, it increases operative mortality by 3 to 8 times, lengthens ICU and hospital stays, and dramatically increases healthcare costs. Even mild AKI is a major predictor of long-term outcomes, particularly chronic kidney disease. The kidney is especially vulnerable to both hypotension and excessive vasopressor use. Multiple perioperative and ICU studies have demonstrated correlations between norepinephrine exposure (dose and duration) and increased AKI incidence.
Despite the importance of accurate BP measurement, the debate regarding the optimal site for arterial monitoring remains unresolved. Radial catheterization is less invasive and easier to perform but may result in excessive vasopressor use and associated complications. In contrast, femoral arterial monitoring may offer more precise pressure readings and thereby improve the safety and efficiency of hemodynamic optimization in critically ill or surgical patients.
The central hypothesis of this study is that invasive arterial pressure monitoring at the femoral site is associated with a reduced number of patients requiring vasopressor therapy (e.g., norepinephrine), compared to monitoring at the radial site.
While clinical guidelines address central venous access and the use of ultrasound guidance, no current recommendations specify the optimal arterial site for BP monitoring, primarily due to a lack of high-quality evidence. This study aims to fill that gap, focusing on a routine clinical practice-arterial pressure monitoring in perioperative and critical care settings.
A better understanding of the clinical implications of the measurement site could lead to more precise recommendations for invasive BP monitoring and improve patient care. Results from this trial may influence: the choice of arterial catheterization site, the use and duration of vasopressor therapy, the incidence of renal and cardiovascular complications.
Should this study demonstrate that femoral arterial monitoring improves clinical outcomes, it could lead to changes in clinical practice guidelines and initiate larger-scale investigations in various other critical care and surgical populations.
- Conditions
- Vasoplegia Syndrome, Vasoplegia, Cardiac Surgical Procedures, Arterial Pressure, Hypotension During Surgery, Hypotension Postprocedural
- Being tested
- Femoral artery catheterization for continuous invasive arterial blood pressure monitoring, Radial artery catheterization for continuous invasive arterial blood pressure monitoring
- Keywords
- Invasive arterial blood pressure monitoring, Vasoplegia syndrome, Cardiac surgery, Norepinephrine
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral artery catheterization for continuous invasive arterial blood pressure monitoringOther
Femoral artery catheterization allow for continuous invasive arterial blood pressure monitoring.
Radial artery catheterization for continuous invasive arterial blood pressure monitoringOther
Radial artery catheterization allows for continuous invasive arterial blood pressure monitoring
| Study group | Role | What they receive |
|---|---|---|
| Femoral group | Active comparator | Patients in the femoral group undergo femoral artery catheterization for continuous invasive arterial blood pressure monitoring. Receives: 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. Receives: Other: Radial artery catheterization for continuous invasive arterial blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after surgery
Secondary outcomes (13)
Rate of renal complications
Rate of renal complications defined as acute kidney injury according to the KDIGO criteria and/or the need for renal replacement therapy
Measured: Within 7 days after surgery
Rate of cardiac complications
Rate of cardiac complications including: arrhythmias requiring treatment (atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation), myocardial injury (defined by an elevation of troponin I or T >99 percentile of the upper reference limit or >20% from the preoperative value), myocardial infarction (defined by elevated cardiac enzymes [cardiac troponin or high-sensitivity cardiac troponin] associated with new Q waves and/or wall motion abnormalities on echocardiography), cardiogenic shock (requiring inotropic support), cardiac arrest
Measured: Within 7 days after surgery
Maximum vasoactive-inotropic score (VIS)
Higher value of the vasoactive-inotropic score (VIS) (VIS = Dopamine (μg/kg/min) + Dobutamine (μg/kg/min) + 100 × Epinephrine (μg/kg/min) + 100 × Norepinephrine (μg/kg/min) + 10 × Milrinone (μg/kg/min) + 10,000 × Vasopressin (U/kg/min) + 100 × Phenylephrine (μg/kg/min)
Measured: Intraoperatively, during the surgery, from surgical incision to end of surgery, in the operating room
Vasoactive-inotropic score (VIS) value
Value of the vasoactive-inotropic score (VIS) (VIS = Dopamine (μg/kg/min) + Dobutamine (μg/kg/min) + 100 × Epinephrine (μg/kg/min) + 100 × Norepinephrine (μg/kg/min) + 10 × Milrinone (μg/kg/min) + 10,000 × Vasopressin (U/kg/min) + 100 × Phenylephrine (μg/kg/min)
Measured: At admission in the postoperative intensive care unit (ICU) (up to 2 hours after surgery)
Maximum vasoactive-inotropic score (VIS) value
Higher value of the vasoactive-inotropic score (VIS) (VIS = Dopamine (μg/kg/min) + Dobutamine (μg/kg/min) + 100 × Epinephrine (μg/kg/min) + 100 × Norepinephrine (μg/kg/min) + 10 × Milrinone (μg/kg/min) + 10,000 × Vasopressin (U/kg/min) + 100 × Phenylephrine (μg/kg/min)
Measured: Within 1 day after surgery
Maximal dose of norepinephrine therapy
Higher rate of norepinephrine infused, expressed in µg/kg/min
Measured: Within 7 days after surgery
Rate of intraoperative hypotension episodes
Rate of intraoperative hypotensive episodes, defined as a mean arterial pressure (MAP) < 65 mmHg for at least 5 minutes
Measured: Intraoperatively, during the surgery, from surgical incision to end of surgery, in the operating room
Cumulative duration of norepinephrine support
Total cumulative duration of norepinephrine support, expressed in hours.
Measured: Within 7 days after surgery
Cumulative duration of any vasopressor therapy
Total cumulative duration of any vasopressor therapy, expressed in hours
Measured: Within 7 days after surgery
Rate of complications related to arterial catheterization and invasive arterial pressure monitoring
Complications related to invasive arterial pressure monitoring including: catheter placement failure, device malfunction, hematoma or bleeding at the insertion site, arterial thrombosis and/or occlusion, and arterial site infection
Measured: Within 7 days after surgery
ICU length of stay
Total cumulative duration of ICU stay from the date of surgery (Day 0) up to postoperative Day 30, inclusive.
Measured: Within 30 days after surgery
Hospital length of stay
Total cumulative duration of hospital stay from the date of surgery (Day 0) up to postoperative Day 30, inclusive.
Measured: Within 30 days after surgery
Mortality
Day 7 and Day 30 mortality
Measured: Within 7 and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Jun 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasoplegia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guillaume BESCH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guillaume BESCH, Centre Hospitalier Universitaire de Besancon
- Investigators
- Guillaume Besch, M.D., Ph.D., Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952907
- Sponsor's protocol ID
- 2024/897
- Acronym
- FERARI
- Status last verified
- Dec 2025
- First submitted
- 18 Apr 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol will be published. The French legislation did not allow for IPD.
Publications
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.
PubMed 41605595
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Versus Radial Artery Catheterization for Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients: the FERARI Randomized Superiority Study
- ClinicalTrials.gov ID
- NCT06952907
- Acronym / sponsor ID
- FERARI / 2024/897
- Conditions
- Vasoplegia Syndrome, Vasoplegia, Cardiac Surgical Procedures, Arterial Pressure, Hypotension During Surgery, Hypotension Postprocedural
- Keywords
- Invasive arterial blood pressure monitoring, Vasoplegia syndrome, Cardiac surgery, Norepinephrine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Guillaume BESCHUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute circulatory failure or shock-typically characterized by arterial hypotension-is a major cause of ICU admission and a significant contributor to postoperative complications in surgery. This condition may result from various pathophysiological mechanisms such as arterial vasodilation, hypovolemia, or low cardiac output, frequently triggered by sepsis, inflammation, surgery, or hemorrhage. Hypotension leads to hypoperfusion of vital organs (kidney, brain, heart), significantly increasing patient morbidity and mortality. Consequently, numerous studies have focused on identifying critical blood pressure thresholds and optimizing therapeutic strategies to reduce associated organ dysfunction and mortality.
A key challenge in the management of hypotension is the accuracy of blood pressure (BP) measurement. In clinical practice, invasive arterial pressure is commonly monitored at radial, brachial, or femoral sites. The radial artery is often preferred for its accessibility and ease of catheterization. However, from a physiological standpoint, the radial artery's small diameter and peripheral location can result in discrepancies when compared to central aortic pressure-the actual pressure driving organ perfusion.
Several studies have shown that in states of shock or acute circulatory failure, radial artery pressure measurements often underestimate actual blood pressure compared to more central measurements such as femoral artery pressure. This difference is particularly pronounced in specific physiological and pathological conditions-e.g., during vasoconstrictor use-where systolic pressure gradients between radial and femoral sites may be significant.
As such, accurate blood pressure monitoring is critical in anesthesia and critical care to guide fluid resuscitation, vasopressor therapy, and interpretation of hemodynamic monitoring tools. Inaccurate measurements may lead to excessive exposure to hypotension or unnecessary administration of vasopressors, both of which carry associated risks.
Scientific literature comparing radial and femoral arterial BP monitoring is limited, outdated (mainly from the 1990s), and largely based on observational data. It is well-established that radial artery monitoring can lead to spuriously low BP readings, resulting in inappropriate hemodynamic management, including excessive fluid resuscitation or vasopressor administration.
Observational studies consistently report the following findings:
A systematic pressure gradient (at least 5-10 mmHg in mean arterial pressure) between femoral and radial sites.
The radial site underestimates femoral BP, and thus organ perfusion pressure. This gradient is more pronounced in critically ill patients, particularly those receiving vasopressors, women, or those with severe illness (e.g., refractory shock, sepsis).
These discrepancies in BP measurement are associated with overuse of hemodynamic drugs. Previous studies reported that over one-third of patients had a significant BP gradient between radial and femoral sites-often leading to excessive vasopressor administration. Other works further support this, indicating higher rates of adverse events, including acute kidney injury (AKI), and excessive vasopressor use in patients monitored at the radial site versus the femoral site.
AKI, frequently observed during shock or in surgical patients, is a key concern. In its severe form, it increases operative mortality by 3 to 8 times, lengthens ICU and hospital stays, and dramatically increases healthcare costs. Even mild AKI is a major predictor of long-term outcomes, particularly chronic kidney disease. The kidney is especially vulnerable to both hypotension and excessive vasopressor use. Multiple perioperative and ICU studies have demonstrated correlations between norepinephrine exposure (dose and duration) and increased AKI incidence.
Despite the importance of accurate BP measurement, the debate regarding the optimal site for arterial monitoring remains unresolved. Radial catheterization is less invasive and easier to perform but may result in excessive vasopressor use and associated complications. In contrast, femoral arterial monitoring may offer more precise pressure readings and thereby improve the safety and efficiency of hemodynamic optimization in critically ill or surgical patients.
The central hypothesis of this study is that invasive arterial pressure monitoring at the femoral site is associated with a reduced number of patients requiring vasopressor therapy (e.g., norepinephrine), compared to monitoring at the radial site.
While clinical guidelines address central venous access and the use of ultrasound guidance, no current recommendations specify the optimal arterial site for BP monitoring, primarily due to a lack of high-quality evidence. This study aims to fill that gap, focusing on a routine clinical practice-arterial pressure monitoring in perioperative and critical care settings.
A better understanding of the clinical implications of the measurement site could lead to more precise recommendations for invasive BP monitoring and improve patient care. Results from this trial may influence: the choice of arterial catheterization site, the use and duration of vasopressor therapy, the incidence of renal and cardiovascular complications.
Should this study demonstrate that femoral arterial monitoring improves clinical outcomes, it could lead to changes in clinical practice guidelines and initiate larger-scale investigations in various other critical care and surgical populations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral group | Active comparator | Other: Femoral artery catheterization for continuous invasive arterial blood pressure monitoringPatients in the femoral group undergo femoral artery catheterization for continuous invasive arterial blood pressure monitoring. |
| Radial group | Active comparator | Other: Radial artery catheterization for continuous invasive arterial blood pressure monitoringPatients in the arterial group undergo arterial artery catheterization for continuous invasive arterial blood pressure monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral artery catheterization for continuous invasive arterial blood pressure monitoringFemoral artery catheterization allow for continuous invasive arterial blood pressure monitoring. | Other | Femoral group |
| Radial artery catheterization for continuous invasive arterial blood pressure monitoringRadial artery catheterization allows for continuous invasive arterial blood pressure monitoring | Other | Radial group |
Primary outcome
Number of patients treated with continuous intravenous norepinephrine
Time frame: Within 7 days after surgery
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.
13 secondary outcomes
Rate of renal complications
Time frame: Within 7 days after surgery
Rate of cardiac complications
Time frame: Within 7 days after surgery
Maximum vasoactive-inotropic score (VIS)
Time frame: Intraoperatively, during the surgery, from surgical incision to end of surgery, in the operating room
Vasoactive-inotropic score (VIS) value
Time frame: At admission in the postoperative intensive care unit (ICU) (up to 2 hours after surgery)
Maximum vasoactive-inotropic score (VIS) value
Time frame: Within 1 day after surgery
Maximal dose of norepinephrine therapy
Time frame: Within 7 days after surgery
Rate of intraoperative hypotension episodes
Time frame: Intraoperatively, during the surgery, from surgical incision to end of surgery, in the operating room
Cumulative duration of norepinephrine support
Time frame: Within 7 days after surgery
Cumulative duration of any vasopressor therapy
Time frame: Within 7 days after surgery
Rate of complications related to arterial catheterization and invasive arterial pressure monitoring
Time frame: Within 7 days after surgery
ICU length of stay
Time frame: Within 30 days after surgery
Hospital length of stay
Time frame: Within 30 days after surgery
Mortality
Time frame: Within 7 and 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 41605595Guinot 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.
- Individual participant dataSharing planned: No. The protocol will be published. The French legislation did not allow for IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Besch, M.D., Ph.D. principal investigator
Centre Hospitalier Universitaire de Besancon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral artery catheterization for continuous invasive arterial blood pressure monitoring and Radial artery catheterization for continuous invasive arterial blood pressure monitoring in people with Vasoplegia Syndrome and Vasoplegia, run by Guillaume BESCH at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Besch, M.D., Ph.D. (+333 812 189 58, gbesch@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated with continuous intravenous norepinephrine (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.