Hemodynamic Monitoring Carotid Surgery (PREST)

May 14, 2025 updated by: RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

patients scheduled for carotid endoarterectomy will be randomly assigned to a group in which arterial hypotension will be avoided by a predictive haemodynamic approach or to a group in which arterial hypotension will be treated in a standard manner

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- >18 years old patients

Exclusion Criteria:

  • Body MassIndex > 35 Kg /m2;
  • Atrial Fibrillation
  • Urgent surgery
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: predictive
Other: predictive approach to hemodynamic management
vasoactive drugs and fluids will be given based on the hypotension prediction index
No Intervention: standard
hemodynamic optimization will be made based on a standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stump pressure
Time Frame: during surgery
we will compare the value of stump pressure between the two groups. the stump pressure will be measured after clamping the common and external carotid vessels
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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