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

NCT07510451 | Recruiting DMC

• 1 other identifier: 808/25
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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 Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours; Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours

Keywords

hypotension; Hypotension Prediction Index; Acumen IQ; FloTrac; haemodynamic monitoring,; aortic abdominal surgery; major vascular surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

• Composite postoperative organ complications within 7 days

  7 postoperative days

• Intraoperative hypertension

  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

  postoperative 90 days

Study Arms (2)

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.

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).

Device: Standard Heamodynamic Managament according to APCO Monitoring

Interventions

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.

HPI-guided haemodynamic management (HPI group)

Standard Heamodynamic Managament according to APCO Monitoring DEVICE

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

standard arterial pressure-derived cardiac output monitoring (FloTrac group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy

Poznan, Poznań, 61-355, Poland

RECRUITING

Related Publications (12)

• 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.

  PMID: 39746186 BACKGROUND

• Giustiniano 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.

  PMID: 39948674 BACKGROUND

• Pilakouta 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.

  PMID: 39048785 BACKGROUND

• Sun 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.

  PMID: 28602158 BACKGROUND

• Szrama 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.

  PMID: 41464693 BACKGROUND

• Ranucci 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.

  PMID: 30481996 BACKGROUND

• Hatib 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.

  PMID: 29894315 BACKGROUND

• Giglio 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.

  PMID: 22833509 BACKGROUND

• Messina 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.

  PMID: 33522953 BACKGROUND

• Beaulieu 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.

  PMID: 31800003 BACKGROUND

• Sessler 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.

  PMID: 29868971 BACKGROUND

• Wesselink 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.

  PMID: 30236233 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paweł Sobczyński, Professor

  Department of Anesthesiology and Intensive Therapy, Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Jakub Szrama, PhD

CONTACT

+48611613280; jakub.szrama@usk.poznan.pl

Mariusz Gezela

CONTACT

+48611613250; mariusz.gezela@usk.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: April 3, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

PL (1)