Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06926010

Effect of a Predictive Hemodynamic Approach on the Stump Pressure During Carotid Endoartectomy: a Randomized Controlled Trial

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-05-18

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial involves patients undergoing carotid endoarterectomy surgery. It aims to compare two methods of managing arterial blood pressure during surgery: one that uses a predictive hemodynamic approach to avoid low blood pressure, and a standard method that treats low blood pressure if it occurs. The study is randomized and designed to evaluate the effect of these approaches on stump pressure during the procedure. Participants will be assigned to one of two groups. In the experimental group, blood pressure will be managed using a predictive approach that guides the use of vasoactive drugs and fluids based on a hypotension prediction index. The control group will receive standard hemodynamic optimization according to a standard protocol. The study begins at surgery and focuses on monitoring blood pressure and stump pressure. During the study, participants will undergo monitoring of stump pressure during surgery. Researchers will measure and compare stump pressures between groups to assess the impact of the predictive hemodynamic management. The trial will follow patients from the start date in April 2025 until its completion expected in April 2027. Safety and treatment effectiveness will be observed during and immediately after surgery.

CONDITIONS

Brief Title

Hemodynamic Monitoring Carotid Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
Not Eligible

You will not qualify if you...

  • Body Mass Index greater than 35 kg/m2
  • Presence of atrial fibrillation
  • Urgent surgery
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo carotid endarterectomy surgery with hemodynamic management guided by either a predictive approach or standard protocol. Vasoactive drugs and fluids may be administered during surgery based on the hypotension prediction index or standard care.

1 surgery day with immediate post-operative monitoring

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Policlinico Gemelli

Rome, Italy

Actively Recruiting

Loading map...

Research Team

A

andrea russo, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Multicenter, Single-arm, Pivotal Study to Evaluate Acute D...

Carotid Artery Diseases

Actively Recruiting

8 locations

Assessing Neurocognition After Cerebrovascular Intervention

Carotid Artery Diseases

Actively Recruiting

1 location

Evaluation of New Biomarkers in the Identification of Unstab...

Carotid Artery Diseases

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here