The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery (HYPE-AORTA)

April 23, 2026 updated by: Jakub Szrama, Poznan University of Medical Sciences

The Hypotension Prediction Index Software Compared With Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery: A Prospective Randomized Controlled Trial

The standard procedure during general anesthesia is to monitor vital functions, including cardiovascular functions such as cardiac electrical activity, using continuous ECG recording, blood pressure measurement with a sphygmomanometer, heart rate measurement, and tissue oxygenation measurement with a pulse oximeter. These are non-invasive methods, which are often insufficient in the case of extensive procedures within the abdominal aorta. In such cases, the anesthesiologist additionally use direct blood pressure measurements and central venous pressure measurements. To perform these measurements, it is necessary to insert a cannula into an artery (usually the radial artery) and a catheter into the central veins (through the internal jugular or subclavian vein). Vascular cannulation is an invasive method and may be associated with complications such as vascular thrombosis, infection at the puncture site or catheter-related infections, pneumothorax, air embolism, cardiac arrhythmias, neuropathies, hematomas, and bleeding. At the same time, they allow for a more accurate assessment of cardiovascular function and the implementation of appropriate treatment, including the administration of large amounts of infusion fluids, vasoconstrictors, and cardiac support drugs.

In the current study, the investigators will additionally use a special sensor and monitor to assess the heart's performance (cardiac output) and its response to the treatment used, optimizing and supporting the circulatory system. This monitoring requires the insertion of a catheter into a central vein and artery, which is necessary during vascular surgery procedures and does not involve any additional invasive procedures. In the postoperative period, the investigators will analyze the frequency of abnormalities in laboratory tests routinely collected after surgery and the function of the central nervous system by performing simple non-invasive cognitive function tests.

The benefits of using the method of assessing the patient's response to surgery and anesthesia in presented study are related to increased safety for each patient and improved perioperative treatment for all patients undergoing surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. American Society of Anesthesiologists (ASA) physical status classification III or IV
  3. Scheduled for elective major abdominal aortic surgery (open or endovascular repair) with an expected surgical duration exceeding 2 hours
  4. Able to provide written informed consent

Exclusion Criteria:

  1. Emergency or urgent surgery
  2. Pregnancy or breastfeeding or positive/uncertain pregnancy test

  3. Haemodynamically significant valvular heart disease:

    • Severe aortic stenosis (aortic valve area < 1.5 cm^2)
    • Moderate to severe aortic regurgitation
    • Moderate to severe mitral regurgitation
    • Moderate to severe mitral stenosis
  4. Severe heart failure with left ventricular ejection fraction < 35%
  5. Permanent atrial fibrillation (reduces accuracy of pulse contour analysis)
  6. Inability to provide informed consent
  7. Participation in another interventional trial that may influence haemodynamic management or study outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HPI-guided haemodynamic management (HPI group)

Patients allocated to the HPI group will receive haemodynamic monitoring using the Acumen IQ sensor (Edwards Lifesciences, Irvine, CA, USA) connected to the radial arterial line. The Acumen IQ system provides all parameters available with the FloTrac sensor, plus additional advanced metrics including dynamic arterial elastance (Ea_dyn), the rate of ventricular pressure change (dP/dt), and the Hypotension Prediction Index (HPI).

The HPI is a machine learning-derived value ranging from 0 to 100 that represents the probability of MAP falling below 65 mmHg within the next 15 minutes. When HPI exceeds 85, the system generates an alert and displays a secondary screen presenting real-time haemodynamic parameters and suggested interventions. Haemodynamic management in the HPI group will follow a structured protocol incorporating both predictive (HPI-triggered) and reactive (MAP-based) components.
Device: HPI guided heamodynamic monitoring
The investigators hypothesise that HPI-guided haemodynamic management, when implemented with protocol refinements to mitigate hypertensive overcorrection, will reduce the burden of intraoperative hypotension compared with standard APCO monitoring in patients undergoing major abdominal aortic surgery. Secondary objectives include evaluation of postoperative organ injury, assessment of intraoperative hypertension as a safety outcome, and characterisation of fluid and vasopressor requirements. By testing this hypothesis in a rigorously designed, adequately powered trial, the investigators aim to clarify whether predictive haemodynamic monitoring offers clinically meaningful advantages over current reactive approaches in this high-risk population.
Active Comparator: standard arterial pressure-derived cardiac output monitoring (FloTrac group)

Patients allocated to the FloTrac group will receive haemodynamic monitoring using the FloTrac sensor (Edwards Lifesciences, Irvine, CA, USA) connected to the radial arterial line. The FloTrac system provides continuous measurements of cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI), stroke volume variation (SVV), systemic vascular resistance (SVR), and systemic vascular resistance index (SVRI) based on arterial pressure waveform analysis.

Haemodynamic management in the FloTrac group will follow a structured protocol designed to maintain MAP ≥ 75 mmHg while avoiding excessive hypertension (target MAP ≤ 100 mmHg).
Device: Standard Heamodynamic Managament according to APCO Monitoring
Standard Heamodynamic Managament according to APCO Monitoring with MAP target of 75 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time-weighted average of mean arterial pressure below 65 mmHg (TWA-MAP < 65 mmHg)
Time Frame: From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
The primary outcome is the time-weighted average of mean arterial pressure below 65 mmHg (TWA-MAP < 65 mmHg) during the period from induction of anaesthesia to departure from the operating theatre.
From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite postoperative organ complications within 7 days
Time Frame: 7 postoperative days

At least one of the following:

  • Acute kidney injury (AKI) according to KDIGO criteria
  • Myocardial injury after non-cardiac surgery (MINS), defined as troponin elevation ≥ assay-specific 99th percentile upper reference limit
  • Stroke (new focal neurological deficit confirmed by neuroimaging)

  • Postoperative respiratory failure will be defined as a composite endpoint reflecting clinically relevant impairment of gas exchange or ventilation in the early postoperative period. It will be considered present if at least one of the following criteria is met within 7 days after surgery or before ICU discharge:

    1. Prolonged invasive mechanical ventilation, defined as failure to extubate within 48 hours after the end of surgery;
    2. Unplanned reintubation with initiation of invasive mechanical ventilation due to respiratory failure (hypoxaemia, hypercapnia, or inability to maintain adequate ventilation) after initial extubation; or
    3. Unplanned initiation of non-invasive ventilation or high-flo
7 postoperative days
Intraoperative hypertension
Time Frame: From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
  • Total time with MAP > 90 mmHg (minutes and % of monitoring time)
  • Total time with MAP > 100 mmHg (minutes and % of monitoring time)
  • TWA-MAP > 90 mmHg and TWA-MAP > 100 mmHg
From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
All-cause mortality at 90 days
Time Frame: postoperative 90 days
All-cause mortality at 90 days
postoperative 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Study Chair: Paweł Sobczyński, Professor, Department of Anesthesiology and Intensive Therapy, Poznan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 808/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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