NCT05481047

Brief Summary

In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

July 22, 2022

Last Update Submit

February 3, 2026

Conditions

Hypotension During SurgeryHemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Cerebral tissue oximetry

    the difference among the two groups of the percentage value of the median value of Cerebral Oxygen Saturation measured by the near-nfrared spectroscopic technology (Foresight sensor)

    immediately after surgery

Study Arms (2)

prevention

EXPERIMENTAL

investigator will prevent intraoperative arterial hypotension based on HPI index

Device: HPI

treatment

NO INTERVENTION

investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

Interventions

HPIDEVICE

based on HPI values, clinicians will administer drugs or fluids in order to avoid arterial hypotension

prevention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients scheduled for abominal surgery

You may not qualify if:

  • Emergency surgery
  • end-stage renal disease
  • pregnancy
  • obesity
  • atrial fibrillation
  • previous cerebral ischaemia
  • central nervous system disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitairo Agostino Gemelli

Roma, RM, 00148, Italy

Location

Study Officials

  • Andrea Russo, MD

    Fondazione Policlinico Universitario Agostino Gemelli

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

July 22, 2022

First Posted

August 1, 2022

Study Start

September 1, 2022

Primary Completion

April 1, 2023

Study Completion

March 22, 2024

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

IT(1)