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NCT Number: NCT07510451

The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Emergency or urgent surgery
  • Pregnancy or breastfeeding or positive/uncertain pregnancy test
  • 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
  • Severe heart failure with left ventricular ejection fraction < 35%
  • Permanent atrial fibrillation (reduces accuracy of pulse contour analysis)
  • Inability to provide informed consent
  • Participation in another interventional trial that may influence haemodynamic management or study outcomes

Treatment and study plan

HPI guided heamodynamic monitoring

Device

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.

Standard Heamodynamic Managament according to APCO Monitoring

Device

Standard Heamodynamic Managament according to APCO Monitoring with MAP target of 75 mmHg

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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
  2. All-cause mortality at 90 days

    Time frame: postoperative 90 days

    All-cause mortality at 90 days

  3. Composite postoperative organ complications within 7 days

    Time frame: 7 postoperative days

    Composite endpoint: at least one of the following within 7 days after surgery.

    • Acute kidney injury (AKI) per KDIGO criteria.
    • Myocardial injury after non-cardiac surgery (MINS): troponin ≥ assay-specific 99th-percentile upper reference limit.
    • Stroke: new focal neurological deficit confirmed by neuroimaging.
    • Postoperative respiratory failure (within 7 days or before ICU discharge): failure to extubate within 48 h; unplanned reintubation for respiratory failure; or unplanned non-invasive ventilation / high-flow nasal oxygen ≥ 6 h after extubation.
    • Postoperative circulatory failure (within 48 h): norepinephrine ≥ 0.1 µg/kg/min for ≥ 6 h despite adequate fluid resuscitation; initiation/escalation of inotropes for tissue hypoperfusion; or mechanical circulatory support (IABP, ECMO, or equivalent).

    Full operational definitions are provided in the study protocol.

Study contacts

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

Jakub Szrama, PhD

CONTACT

[email protected]

+48611613280

Mariusz Gezela

CONTACT

[email protected]

+48611613250

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: HYPE-AORTA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2026
Registry last updated
Jul 14, 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.

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