Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 HoursHYPE-AORTANCT07510451
The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery
A study testing HPI guided heamodynamic monitoring and Standard Heamodynamic Managament according to APCO Monitoring in people with 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, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours
- What is being tested?
- HPI guided heamodynamic monitoring and Standard Heamodynamic Managament according to APCO Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 29 Jan 2026to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Therapy
Poznan, 61-355
Jakub Szrama, PhD, +48611613280, jakub.szrama@usk.poznan.pl
Mariusz Gezela, +48611613250, mariusz.gezela@usk.poznan.pl
About this study
Official title: 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.
- Conditions
- Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours
- Being tested
- HPI guided heamodynamic monitoring, Standard Heamodynamic Managament according to APCO Monitoring
- Keywords
- hypotension, Hypotension Prediction Index, Acumen IQ, FloTrac, haemodynamic monitoring,, aortic abdominal surgery, major vascular surgery
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPI guided heamodynamic monitoringDevice
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 MonitoringDevice
Standard Heamodynamic Managament according to APCO Monitoring with MAP target of 75 mmHg
| Study group | Role | What they receive |
|---|---|---|
| HPI-guided haemodynamic management (HPI group) | Active comparator | 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. Receives: Device: HPI guided heamodynamic monitoring |
| standard arterial pressure-derived cardiac output monitoring (FloTrac group) | Active comparator | 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). Receives: Device: Standard Heamodynamic Managament according to APCO Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start29 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 HoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Szrama, Poznan University of Medical Sciences
- Investigators
- Paweł Sobczyński, Professor, Study chair, Department of Anesthesiology and Intensive Therapy, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510451
- Sponsor's protocol ID
- 808/25
- Acronym
- HYPE-AORTA
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ripolles-Melchor J, Tome-Roca JL, Zorrilla-Vaca A, Aldecoa C, Colomina MJ, Bassas-Parga E, Lorente JV, Ruiz-Escobar A, Carrasco-Sanchez L, Sadurni-Sarda M, Rivas E, Puig J, Agudelo-Montoya E, Del Rio-Fernandez S, Garcia-Lopez D, Adell-Perez AB, Guillen A, Venturoli-Ojeda R, Fernandez-Torres B, Abad-Motos A, Mojarro I, Garrido-Calmaestra JL, Fernanz-Anton J, Pedregosa-Sanz A, Cueva-Castro L, Echevarria-Correas MA, Mallol M, Olvera-Garcia MM, Navarro-Perez R, Fernandez-Valdes-Bango P, Garcia-Fernandez J, Espinosa AV, Abu Khudair H, Becerra-Bolanos A, Diez-Remesal Y, Fuentes-Pradera MA, Valbuena-Bueno MA, Quintana-Villamandos B, Llorca-Garcia J, Fernandez-Lopez I, Ocon-Moreno A, Martin-Infantes SL, Valiente-Lourtau JM, Amelburu-Egoscozabal M, Rivera-Ramos H, Abad-Gurumeta A, Monge-Garcia MI; HYT Group. Hemodynamic Management Guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial. Anesthesiology. 2025 Apr 1;142(4):639-654. doi: 10.1097/ALN.0000000000005355. Epub 2025 Jan 2.
PubMed 39746186Giustiniano E, Nisi F, Ferrod F, Lionetti G, Viscido C, Reda A, Piccioni F, Buono G, Cecconi M. Intraoperative hemodynamic management in abdominal aortic surgery guided by the Hypotension Prediction Index: the Hemas multicentric observational study. J Anesth Analg Crit Care. 2025 Feb 13;5(1):7. doi: 10.1186/s44158-024-00222-x.
PubMed 39948674Pilakouta Depaskouale MA, Archonta SA, Katsaros DM, Paidakakos NA, Dimakopoulou AN, Matsota PK. Beyond the debut: unpacking six years of Hypotension Prediction Index software in intraoperative hypotension prevention - a systematic review and meta-analysis. J Clin Monit Comput. 2024 Dec;38(6):1367-1377. doi: 10.1007/s10877-024-01202-w. Epub 2024 Jul 24.
PubMed 39048785Sun Y, Chai F, Pan C, Romeiser JL, Gan TJ. Effect of perioperative goal-directed hemodynamic therapy on postoperative recovery following major abdominal surgery-a systematic review and meta-analysis of randomized controlled trials. Crit Care. 2017 Jun 12;21(1):141. doi: 10.1186/s13054-017-1728-8.
PubMed 28602158Szrama J, Gezela M, Zuranski L, Kulas K, Gajda M, Smuszkiewicz P, Sobczynski P. Hypotension Prediction Index Software Compared with Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery: A Retrospective Study. J Clin Med. 2025 Dec 12;14(24):8791. doi: 10.3390/jcm14248791.
PubMed 41464693Ranucci M, Barile L, Ambrogi F, Pistuddi V; Surgical and Clinical Outcome Research (SCORE) Group. Discrimination and calibration properties of the hypotension probability indicator during cardiac and vascular surgery. Minerva Anestesiol. 2019 Jul;85(7):724-730. doi: 10.23736/S0375-9393.18.12620-4. Epub 2018 Nov 22.
PubMed 30481996Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.
PubMed 29894315Giglio M, Dalfino L, Puntillo F, Rubino G, Marucci M, Brienza N. Haemodynamic goal-directed therapy in cardiac and vascular surgery. A systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2012 Nov;15(5):878-87. doi: 10.1093/icvts/ivs323. Epub 2012 Jul 24.
PubMed 22833509Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.
PubMed 33522953Beaulieu RJ, Sutzko DC, Albright J, Jeruzal E, Osborne NH, Henke PK. Association of High Mortality With Postoperative Myocardial Infarction After Major Vascular Surgery Despite Use of Evidence-Based Therapies. JAMA Surg. 2020 Feb 1;155(2):131-137. doi: 10.1001/jamasurg.2019.4908.
PubMed 31800003Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.
PubMed 29868971Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PubMed 30236233