Hypotension Prediction Index (HPI) in Patients Undergoing Robotic Assisted Radical Prostatectomy

NCT ID: NCT06535464

Last Updated: 2024-08-02

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-09-01

Brief Summary

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Robot assisted radical prostatectomy (RARP) is the leader in robotic treatment for prostate cancer. Goal-directed therapy (GDT) is the approach used, but HPI, a machine learning algorithm analysing arterial waveforms, might offer additional benefits. The aim of this prospective randomised study is to evaluate the cumulative amount of intraoperative arterial hypotension episodes in patients undergoing RARP managed by GDT protocol guided or not by HPI algorithm

Detailed Description

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Conditions

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Hypotension During Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Goal-directed therapy guided by Hypotension Prediction Index algorithm

Group Type ACTIVE_COMPARATOR

Hypotension Prediction Index

Intervention Type DEVICE

Fluid management guided by Hypotension Prediction Index

Goal-directed therapy alone

Group Type SHAM_COMPARATOR

No Hypotension Prediction Index

Intervention Type DEVICE

Fluid management not guided by Hypotension Prediction Index

Interventions

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Hypotension Prediction Index

Fluid management guided by Hypotension Prediction Index

Intervention Type DEVICE

No Hypotension Prediction Index

Fluid management not guided by Hypotension Prediction Index

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* all consecutive patients undergoing RARP; American Society of Anaesthesiology (ASA) SCORE I-III

Exclusion Criteria

* Body Mass Index (BMI) of 18.5 to 35, uncontrolled arrhythmias, myocardial infarction or ischemic/hemorrhagic stroke in the last 6 months, III/IV stage Global Initiative for Chronic Obstructive Lung Disease, pulmonary fibrosis, contraindication to radial artery cannulation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Cotoia Antonella

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedali Riuniti

Foggia, Apulia, Italy

Site Status

Countries

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Italy

References

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Antonella C, Discenza A, Rauseo M, Matella M, Caggianelli G, Ciaramelletti R, Mirabella L, Cinnella G. Intraoperative hypotension during robotic-assisted radical prostatectomy: A randomised controlled trial comparing standard goal-directed fluid therapy with hypotension prediction index-guided goal-directed fluid therapy. Eur J Anaesthesiol. 2025 Oct 1;42(10):916-923. doi: 10.1097/EJA.0000000000002211. Epub 2025 Jun 9.

Reference Type DERIVED
PMID: 40493027 (View on PubMed)

Other Identifiers

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135/C.E. 2021

Identifier Type: -

Identifier Source: org_study_id

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