Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery

NCT ID: NCT05481047

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-03-22

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension During Surgery Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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prevention

investigator will prevent intraoperative arterial hypotension based on HPI index

Group Type EXPERIMENTAL

HPI

Intervention Type DEVICE

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

treatment

investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HPI

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for abominal surgery

Exclusion Criteria

* Emergency surgery
* end-stage renal disease
* pregnancy
* obesity
* atrial fibrillation
* previous cerebral ischaemia
* central nervous system disorders
* severe cardiac valvular disease
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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RUSSO ANDREA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Russo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Locations

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Fondazione Policlinico Universitairo Agostino Gemelli

Roma, RM, Italy

Site Status

Countries

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Italy

Other Identifiers

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5079

Identifier Type: -

Identifier Source: org_study_id

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