NCT06932484

Brief Summary

intraoperative hemodynamic optimization will be based on the percentage of variation of the parameters

Trial Health

77
On Track

Trial Health Score

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

Enrollment
104

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

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Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

April 10, 2025

Last Update Submit

July 30, 2025

Conditions

Hemodynamic MAP Stability

Outcome Measures

Primary Outcomes (1)

  • time weighted average of mean arterial pressure

    we will avoid hypotensive episodes by using a predictive approach and then calculate the TWA-MAP \< 65 mmHg

    the end of surgery

Study Arms (2)

delta

EXPERIMENTAL

in this group the trigger for any intervention will be the delta variation of the hemodynamic parameters showed in the monitoring platform

Procedure: parameters

standard

NO INTERVENTION

in this group hemodynamics will be managed by using the hypotension prediction index

Interventions

parametersPROCEDURE

during surgery hemodynamic will be optimized based on percentage variation of different variables

delta

Eligibility Criteria

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

You may not qualify if:

  • Body Mass Index \> 35 kg/m2 Pregnancy Refusal to sign written informed consent Urgent and/or emergency surgery

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, physician

CONTACT

+39-06-30153212andrea.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

April 10, 2025

First Posted

April 17, 2025

Study Start

June 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations

IT(1)