Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07301307

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

This study investigates if the Hypotension Prediction Index (HPI) combined with the Assisted Fluid Management (AFM) software can improve perioperative hemodynamic management in adult patients undergoing general anesthesia. The main question is :

Does the HPI and AFM software reduce the incidence and duration of intraoperative hypotension? Does the HPI and AFM software optimize fluid and vasopressor administration? Does the HPI and AFM software improve perioperative outcomes? Participants will be randomly allocated to either an experimental group receiving goal directed hemodynamic therapy guided by HPI and AFM or a control group receiving conventional hemodynamic management.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd University Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location status: Recruiting

Location contact

Georgia Ntalamagka

CONTACT

[email protected]

+306978210163

About this study

Intraoperative hypotension is a common complication during general anesthesia and is associated with an increased risk of postoperative organ dysfunction (acute kidney injury, myocardial ischemia). Even short episodes of mean arterial pressure (MAP) below accepted thresholds have been shown to adversely affect patient outcomes.

The Hypotension Prediction Index , (HPI)is a software that predicts the likelihood of hypotension minutes before it occurs, based on the arterial waveform. Thus clinicians have the opportunity to identify patients at risk of hypotension and intervene early.

The Assisted Fluid Management (AFM) software is designed to optimize perioperative fluid administration based on the Frank-Starling curve. The AFM provides guidance on crystalloid admininistration only when it is expected to increase stroke volume and cardiac output.

This prospective , randomized study evaluates whether the use of HPI coupled with AFM within a goal directed hemodynamic protocol improves perioperative hemodynamic management and reduces the incidence and duration of adult patients undergoing surgery under general anesthesia.

A total of 100 adult patients will be enrolled , for elective surgery with invasive blood pressure monitoring and intraoperative mean arterial pressure target of at least 65 mm Hg.

Patients in the intervention group will undergo goal directed hemodynamic management guided by HPI and AFM algorithms via the Hemosphere monitor and Acumen IQ sensor. The AFM software will determine the timing of fluid administration. Elevated HPI values indicating impending hypotension will be managed in a targeted manner with fluids, vasopressors or inotropes.

Patients in the control group will receive conventional hemodynamic management , based on clinical judgement, in accordance with international guidelines. Although an Acumen IQ sensor will be placed, HPI and AFM indications will not be visible to the attending anesthesiologist and will not influence clinical decision making.

Intraoperative hemodynamic data will be continuously recorded in both groups. A member of the research team will be present to supervise the procedure. The primary outcome is the time-weighted average of hypotension, defined as MAP below 65 mm Hg for at least one minute. Secondary outcomes include the incidence and duration of hypotension, type and dose of administered therapies and protocol adherence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Intraoperative monitoring > 2 hours or general anesthesia > 2 hours
  • Invasive arterial pressure monitoring
  • Target MAP ≥ 65 mm Hg intraoperatively
  • Written informed consent preoperatively
  • ASA Physical Status ≤ 4

Exclusion criteria

  • Target MAP other than 65 mm Hg
  • Severe preoperative hypotension (MAP < 65 mm Hg)
  • Severe heart failure (e.g. LVEF < 20%)
  • Emergency surgery

Treatment and study plan

Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software

Device

The Acumen IQ sensor will be used with the Hemosphere monitor to guide goal-directed hemodynamic therapy. HPI predicts impending hypotension and AFM guides fluid administration. Clinicians will follow a protocol algorithm to prevent or treat intraoperative hypotension with fluids, vasopressors or inotropes.

Conventional Intraoperative Hemodynamic management

Other

Participants receive hemodynamic management based on the anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed , but HPI and AFM outputs are not visible to the clinician.

Primary outcomes

  1. Time-weighted average of intraoperative hypotension

    Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

    Time weighted average spent in hypotension, defined as mean arterial pressure (MAP) <65mmHg for ≥ 1min, measures using the Acumen IQ sensor and Hemosphere monitor.

Secondary outcomes

  1. Incidence of hypotension

    Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

    Incidence of hypotension, defined as MAP <65mmHg for ≥ 1min.

  2. Time spent in hypotension

    Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

    Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥ 1min

  3. Choice of therapy (fluids/medications)

    Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

    Medication used to prevent/treat hypotension. A study member is present at the OR to make notes.

  4. Dose of therapy (fluids/medications)

    Time frame: Intraoperatively, starting 15 minutes after anesthesia induction.

    Dose of medication used to prevent/treat hypotension.

  5. Protocol deviations

    Time frame: Intraoperatively, starting 15 minutes after anesthesia induction

    Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgia Ntalamagka, MD

CONTACT

[email protected]

+306978210163

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Attikon Hospital

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.