An interventional study of HPI guided heamodynamic monitoring and Standard Heamodynamic Managament according to APCO Monitoring in Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours and Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Prevention
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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 200 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Haemodynamically significant valvular heart disease:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 with MAP target of 75 mmHg
time-weighted average of mean arterial pressure below 65 mmHg (TWA-MAP < 65 mmHg)
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.
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
Intraoperative hypertension
* 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
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
All-cause mortality at 90 days
All-cause mortality at 90 days
Time frame: postoperative 90 days
Composite postoperative organ complications within 7 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.
Time frame: 7 postoperative days
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Poznan University of Medical Sciences →