Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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