Back to results

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

Primary Purpose

Hypotension During Surgery, Hemodynamic Instability

Status

Not yet recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

HPI

About this trial

This is an interventional treatment trial for Hypotension During Surgery

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondazione Policlinico Universitairo Agostino Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prevention

treatment

Arm Description

investigator will prevent intraoperative arterial hypotension based on HPI index

investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05481047

First Posted

July 22, 2022

Last Updated

July 28, 2022

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT05481047

Brief Title

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

Official Title

Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension During Surgery, Hemodynamic Instability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

prevention

Arm Type

Experimental

Arm Description

investigator will prevent intraoperative arterial hypotension based on HPI index

Arm Title

treatment

Arm Type

No Intervention

Arm Description

investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

Intervention Type

Device

Intervention Name(s)

HPI

Intervention Description

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

Primary Outcome Measure Information:

Title

Cerebral tissue oximetry

Description

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)

Time Frame

immediately after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Russo, MD

Phone

06/30154507

russoandreand@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Russo, MD

Organizational Affiliation

Fondazione Policlinico Universitario Agostino Gemelli

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione Policlinico Universitairo Agostino Gemelli

City

Roma

State/Province

ZIP/Postal Code

00148

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lara Cascarano, MD

laura.cascarano30990@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs