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Recruiting NCT06460519

NCT06460519 The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study

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Clinical Trial Summary
NCT ID NCT06460519
Status Recruiting
Phase
Sponsor Hospices Civils de Lyon
Condition Shock
Study Type OBSERVATIONAL
Enrollment 180 participants
Start Date 2024-10-03
Primary Completion 2027-11-03

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 99 Years
Study Type OBSERVATIONAL
Interventions
Non-invasive blood pressure measurements

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 180 participants in total. It began in 2024-10-03 with a primary completion date of 2027-11-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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. 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Matthias Jacquet-lagreze, Dr

✉ matthias.jacquet-lagreze@chu-lyon.fr

📞 0783426888

Frequently Asked Questions

Who can join the NCT06460519 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06460519 currently recruiting?

Yes, NCT06460519 is actively recruiting participants. Contact the research team at matthias.jacquet-lagreze@chu-lyon.fr for enrollment information.

Where is the NCT06460519 trial being conducted?

This trial is being conducted at Bron, France, Lyon, France, Lyon, France, Lyon, France and 2 additional locations.

Who is sponsoring the NCT06460519 clinical trial?

NCT06460519 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 180 participants.

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