NCT06984302

Brief Summary

We will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the Hemosphere platform. In the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 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 Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

May 14, 2025

Last Update Submit

July 30, 2025

Conditions

Hemodynamic

Outcome Measures

Primary Outcomes (1)

  • time weighted average of mean arterial presure under 65 mmHg

    we will assess the magnitude of intraoperative arterial hypotension

    at the end of surgery

Study Arms (2)

proactive group

EXPERIMENTAL

in this group patients will be managed by a predictive hemodynamic algorithm

Other: proactive therapy

control group

NO INTERVENTION

drugs and fluids will be given based on mean arterial pressure and stroke volume variation respectively

Interventions

proactive therapyOTHER

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

proactive group

Eligibility Criteria

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

You may qualify if:

  • planned aortic surgery acceptance of written informed consent

You may not qualify if:

  • body mass index \> 35 kg/m2
  • atrial fibrillation
  • urgent surgery
  • end-stage renal disease
  • pregnancy
  • refusal of the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, 00148, Italy

RECRUITING

Central Study Contacts

Andrea Russo, medical doctor

CONTACT

+39-0630153160andrea.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
MD

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations

IT(1)