ShockPARECHOCNCT06460519
The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study
An observational study of Shock, run by Hospices Civils de Lyon at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Shock
- What is being tested?
- Non-invasive blood pressure measurements
- How many people
- 180 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 3 Oct 2024to 3 Nov 2027
- Phase
- Observational
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 180 patients of intensive care unit (ICU), in shock with equal or more than 0.5µg/kg/min of norepinephrine equivalent, who are not in perioperative of cardiac surgery. And who have a monitoring of arterial pressure by a radial catheter, and for who the physician decided to put in place a femoral arterial catheter.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
France8 sites, 8 recruiting
- Recruiting
Département d'anesthésie Réanimation Hôpital Cardiologique Louis Pradel/Groupement Hospitalier Est
Bron, 69500
Matthias Jacquet-Lagreze, Dr, 0783426888 ext. +33, matthias.jacquet-lagreze@chu-lyon.fr
- Recruiting
Département d'anesthésie-réanimation CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Thomas GODET, Pr, 04 73 75 05 48, tgodet@chu-clermontferrand.fr
Thomas GODET, Pr
- Recruiting
Service d'Anesthésie Association hospitalière Protestante de Lyon
Lyon, 69000
Abdellah Aoufi, Dr, 04 78 83 50 66, aoufi.abdellah@infirmerie-protestante.com
Abdellah Aoufi, Dr
- Recruiting
Hopital Edouard heriot/Groupement hospitalier Centre, service de médecine intensive réanimation
Lyon, 69003
Neven Stevic, Dr, 0472112838 ext. +33, neven.stevic@chu-lyon.fr
- Recruiting
Hôpital Edouard Heriot/ Groupement hospitalier Centre, service d'anesthésie réanimation
Lyon, 69003
Stanislas Abrard, Dr, 0472112310 ext. +33, Stanislas.abrard@chu-lyon.fr
- Recruiting
Hôpital de la Croix-Rousse/Groupement hospitalier Nord, service d'anesthésie réanimation
Lyon, 69004
Marie-Charlotte Delignette, Dr, 0472309070 ext. +33, Marie-charlotte.delignette@chu-lyon.fr
- Recruiting
Hôpital Saint Joseph Saint Luc
Lyon, 69007
Emmanuel Vivier, Dr, 04 78 61 83 98 ext. +33, evivier@saintjosephsaintluc.fr
Emmanuel Vivier, Dr
- Recruiting
Centre hospitalier Lyon Sud/Groupement hospitalier Sud, Service d'anesthésie réanimation médecine intensive
Lyon, 69495
Auguste Dargent, Dr, 04 78 86 20 06 ext. +33, Auguste.dargent@chu-lyon.fr
Guadeloupe1 site, 1 recruiting
- Recruiting
Service de réanimation médico-chirurgicale et traumatologique Centre Hospitalier Universitaire de la Guadeloupe
Les Abymes
Alexandre NOEL, Dr, 05 90 89 11 30, alexandre.noel@chu-guadeloupe.fr
Alexandre NOEL, Dr
About this study
Official title: Prevalence of the Aortic to Radial Pressure Gradient in States of Shock
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.
Read more
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.
- Conditions
- Shock
- Being tested
- Non-invasive blood pressure measurements
- Keywords
- Radial artery, Femoral artery, Norepinephrine equivalent, Intensive care unit
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive blood pressure measurementsOther
Non-invasive blood pressure measurements to the tension cuff three times in a row on each side (right arm and left arm)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-invasive blood pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence (percentage) of ATRAP is determined by the ratio of patients with ATRAP to total. ATRAP is defined by a 25mmHg systolic or 10mmHg mean pressure difference between radial and femoral arterial pressures during more than 5 minutes.
The prevalence of the ATRAP will be show in percentage (%), with his confidence interval at 95%.
Measured: The primary outcome will be measure at the inclusion of the patient when the femoral arterial catheter will be in place.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start3 Oct 2024
- Primary completion3 Nov 2027 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460519
- Sponsor's protocol ID
- 69HCL24_0264
- Acronym
- PARECHOC
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No