Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management

Summary

Intraoperative hypotension (defined as mean arterial pressure below 65 mmHg) is associated with increased organs dysfunction and mortality. Even short durations of reduced arterial blood pressure episodes significantly increased the risk of myocardial injury, neurological deficits, renal failure, and mortality. Hypotension rate during surgery is quite common and recent studies showed an incidence up to 60% of patients endured hypotension during anesthesia for an average of 10% of surgical time.

Nowadays hypotension seems to be preventable even if current management of the hypotensive episodes is predominantly reactive and rather occurs with some delay.

The investigators hypothesize that the prevention of hypotension by means Edwards Lifesciences new technology (HPI software) can improve patients outcome after surgery.

The present pilot randomized clinical trial is aimed at investigating various biomarkers involved in organ dysfunction and how they correlate with different intraoperative hypotension management strategies (Invasive blood pressure monitored by a normal arterial line vs Invasive blood pressure monitored by Edwards FloTracIQ system with HPI software).

Conditions

• Hypotension
• Brain Injuries
• Renal Failure
• Endothelial Dysfunction

Interventions

DEVICE

Flo TracIQ with HPI software

Patients will be monitored intraoperatively with Flo TracIQ with HPI software in order to predict hypotensive events. Blood sample will be obtained in order to evaluate ealy organ dysfunction.

Sponsors & Collaborators

• Giovanni Li Volti

  collaborator UNKNOWN

• Marinella Astuto

  collaborator UNKNOWN

• Francesco Vasile

  collaborator UNKNOWN

• Gaetano Joseph Palumbo

  collaborator UNKNOWN

• Mirko Mineri

  collaborator UNKNOWN

• Christian Bonsignore

  collaborator UNKNOWN

• Salvatore Pennisi

  collaborator UNKNOWN

• Carmelo Minardi

  collaborator UNKNOWN

• Bruno Lanzafame

  collaborator UNKNOWN

• Luigi Lavia

  collaborator UNKNOWN

• Veronica Dezio

  collaborator UNKNOWN

• University of Catania

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2019-11-01

Completion

2020-01-15

Countries

• Italy

Study Locations