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

NCT06535464 | Completed

• 1 other identifier: 135/C.E. 2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotension During Surgery

Outcome Measures

Primary Outcomes (1)

• cumulative amount of time spent in Hypotension

  the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg

  intraoperative

Study Arms (2)

Goal-directed therapy guided by Hypotension Prediction Index algorithm

ACTIVE COMPARATOR

Device: Hypotension Prediction Index

Goal-directed therapy alone

SHAM COMPARATOR

Device: No Hypotension Prediction Index

Interventions

Hypotension Prediction Index DEVICE

Fluid management guided by Hypotension Prediction Index

Goal-directed therapy guided by Hypotension Prediction Index algorithm

No Hypotension Prediction Index DEVICE

Fluid management not guided by Hypotension Prediction Index

Goal-directed therapy alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Ospedali Riuniti

Foggia, Apulia, 71100, Italy

Location

Related Publications (1)

• Cotoia A, 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.

  PMID: 40493027 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: September 1, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)