The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study

NCT ID: NCT06460519

Last Updated: 2025-09-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-03

Study Completion Date

2026-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

First described in cardiac surgery, the aortic to radial pressure gradient (ATRAP) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. The risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm.

The ATRAP definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmHg on the systolic pressure, or a pressure difference on the mean pressure of 10mmHg, both measures realised by arterial canulation, and with a duration superior than 5 minutes.

If this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work.

The ATRAP is documented in septic shock with a prevalence between 21% and 27%. The ATRAP can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. But the prevalence and risks factors are barely unknowns in this situation.

Most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. Some medical teams in cardiac surgeries, or in intensive care unit (ICU) for the management of shocks used often radial and femoral arterial catheter. It seems there is no at risk for the utilisation of a radial and femoral arterial canulation.

Out of the situation of cardiac surgery, there is a lack of information of the ATRAP, the objective of the study is to evaluate the prevalence of the ATRAP in shock, out of the situation of cardiac surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensive care unit patient with shock, who don't be in perioperative of cardiac surgery

Patients of age superior or equal of 18 years, with a vasopressor support superior 0.5 µg/kg/min of equivalent norepinephrine during more than 30 minutes.

The patients are not in perioperative of cardiac surgery (between the beginning of the intervention and 7 days after).

The patients have a monitoring of arterial pressure with a radial arterial catheter, and the physician decided to have a monitoring of arterial pressure with a femoral arterial catheter.

Non-invasive blood pressure measurements

Intervention Type OTHER

Non-invasive blood pressure measurements to the tension cuff three times in a row on each side (right arm and left arm)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-invasive blood pressure measurements

Non-invasive blood pressure measurements to the tension cuff three times in a row on each side (right arm and left arm)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age superior or equal 18 years
* Vasopressors support superior or equal 0.5 µg/kg/min of equivalent norepinephrine
* Invasive monitoring of blood pressure with a radial arterial catheter and a femoral arterial catheter decided by de physician
* Beginning of the shock less than 48 hours.
* Consent

Exclusion Criteria

* perioperative of cardiac surgery (between the beginning of the surgery and 7 days after)
* pregnant woman or breast-feeding
* Major person under protection
* Person with privation of liberty by a justice decision, or an administrative decision
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Département d'anesthésie Réanimation Hôpital Cardiologique Louis Pradel/Groupement Hospitalier Est

Bron, , France

Site Status RECRUITING

Hopital Edouard heriot/Groupement hospitalier Centre, service de médecine intensive réanimation

Lyon, , France

Site Status RECRUITING

Hôpital Edouard Heriot/ Groupement hospitalier Centre, service d'anesthésie réanimation

Lyon, , France

Site Status RECRUITING

Hôpital de la Croix-Rousse/Groupement hospitalier Nord, service d'anesthésie réanimation

Lyon, , France

Site Status RECRUITING

Centre hospitalier Lyon Sud/Groupement hospitalier Sud, Service d'anesthésie réanimation médecine intensive

Lyon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Matthias Jacquet-lagreze, Dr

Role: CONTACT

0783426888 ext. +33

Martin Ruste, Dr

Role: CONTACT

0472118956 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Matthias Jacquet-Lagreze, Dr

Role: primary

0783426888 ext. +33

Neven Stevic, Dr

Role: primary

0472112838 ext. +33

Stanislas Abrard, Dr

Role: primary

0472112310 ext. +33

Marie-Charlotte Delignette, Dr

Role: primary

0472309070 ext. +33

Auguste Dargent, Dr

Role: primary

04 78 86 20 06 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

69HCL24_0264

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.