NCT06926010

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

April 4, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

April 4, 2025

Last Update Submit

May 14, 2025

Conditions

Carotid Artery DiseasesHaemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

  • stump pressure

    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

Study Arms (2)

predictive

EXPERIMENTAL
Other: predictive approach to hemodynamic management

standard

NO INTERVENTION

hemodynamic optimization will be made based on a standard protocol

Interventions

predictive approach to hemodynamic managementOTHER

vasoactive drugs and fluids will be given based on the hypotension prediction index

predictive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- \>18 years old patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Policlinico Gemelli

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

andrea russo, MD

CONTACT

3333926815andrea.russo@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 13, 2025

Study Start

April 10, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)