Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07301307

The Use of the Hypotension Prediction Index (HPI) Combined With the Assisted Fluid Management (AFM) Software for Perioperative Hemodynamic Optimization in Patients Undergoing General Anesthesia

Led by National and Kapodistrian University of Athens · Updated on 2026-04-20

100

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

N

National and Kapodistrian University of Athens

Lead Sponsor

A

Attikon Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating if combining the Hypotension Prediction Index (HPI) with Assisted Fluid Management (AFM) software can improve the management of blood pressure during general anesthesia in adults. The study aims to find out whether using HPI and AFM reduces the occurrence and length of low blood pressure during surgery, optimizes fluid and medication use, and improves overall outcomes. This is a prospective, randomized trial involving adult patients undergoing elective surgery requiring invasive blood pressure monitoring. Participants will be randomly assigned to one of two groups. The experimental group will receive goal-directed hemodynamic therapy guided by HPI and AFM software using the Hemosphere monitor and Acumen IQ sensor. This system helps predict low blood pressure before it happens and guides fluid administration based on heart function. The control group will receive standard care based on the anesthesiologist's clinical judgment; although the Acumen IQ sensor will be used, its outputs will not be visible or used in decision-making. Both groups will be monitored continuously during surgery. Participants will have invasive blood pressure monitoring throughout surgery, with data recorded by the research team. The main measure is the time-weighted average of hypotension, defined as mean arterial pressure below 65 mm Hg for at least one minute during surgery. Secondary measures include how often and how long hypotension occurs, the types and amounts of fluids and medications given, and adherence to the treatment protocol. The study is expected to conclude in March 2027.

CONDITIONS

Brief Title

Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Surgery under general anesthesia expected to last more than 2 hours
  • Invasive arterial pressure monitoring planned during surgery
  • Target mean arterial pressure of at least 65 mm Hg during surgery
  • Written informed consent obtained before surgery
  • ASA Physical Status classification of 4 or less
Not Eligible

You will not qualify if you...

  • Target mean arterial pressure other than 65 mm Hg
  • Severe preoperative hypotension with mean arterial pressure below 65 mm Hg
  • Severe heart failure with left ventricular ejection fraction less than 20%
  • Emergency surgery scheduled

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Surgery duration expected to be more than 2 hours

Participants undergo surgery under general anesthesia. Those in the experimental group receive goal-directed hemodynamic therapy guided by the Hypotension Prediction Index and Assisted Fluid Management software to prevent or treat intraoperative hypotension. Participants in the control group receive conventional hemodynamic management based on clinical judgement. Hemodynamic data are continuously recorded during surgery.

1 intraoperative visit (in-person)

Trial Site Locations

Total: 1 location

1

2nd University Department of Anesthesiology, Attikon University Hospital

Athens, Attica, Greece, 12462

Actively Recruiting

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Research Team

G

Georgia Ntalamagka, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Restrictive versus Decision Support Guided Fluid Therapy during Major Hepatic Resection Surgery: A Randomized Controlled Trial.

Sean Coeckelenbergh, Maxim Soucy-Proulx, Philippe Van der Linden...

https://pubmed.ncbi.nlm.nih.gov/39052844

Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial.

Sean Coeckelenbergh, Marguerite Entzeroth, Philippe Van der Linden...

https://pubmed.ncbi.nlm.nih.gov/39116013

Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching.

Alexandre Joosten, Sean Coeckelenbergh, Amelie Delaporte...

https://pubmed.ncbi.nlm.nih.gov/29750699

Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery.

Alexandre Joosten, Reda Hafiane, Marco Pustetto...

https://pubmed.ncbi.nlm.nih.gov/29779129

Effect of a Machine Learning-Derived Early Warning Tool With Treatment Protocol on Hypotension During Cardiac Surgery and ICU Stay: The Hypotension Prediction 2 (HYPE-2) Randomized Clinical Trial.

Jaap Schuurmans, Santino R Rellum, Jimmy Schenk...

https://pubmed.ncbi.nlm.nih.gov/39576150