Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia

NCT07301307 | Recruiting FDA Device

• 1 other identifier: 641/24-09-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates if the Hypotension Prediction Index (HPI) combined with the Assisted Fluid Management (AFM) software can improve perioperative hemodynamic management in adult patients undergoing general anesthesia. The main question is : Does the HPI and AFM software reduce the incidence and duration of intraoperative hypotension? Does the HPI and AFM software optimize fluid and vasopressor administration? Does the HPI and AFM software improve perioperative outcomes? Participants will be randomly allocated to either an experimental group receiving goal directed hemodynamic therapy guided by HPI and AFM or a control group receiving conventional hemodynamic management.

Conditions

Intraoperative Hypotension

Keywords

Intraoperative Hypotension; Perioperative Hemodynamic Optimization; Goal-Directed Hemodynamic Therapy; Hypotension Prediction Index; Assisted Fluid Management; Invasive Arterial Pressure Monitoring; Artificial Intelligence; Perioperative Care

Outcome Measures

Primary Outcomes (1)

• Time-weighted average of intraoperative hypotension

  Time weighted average spent in hypotension, defined as mean arterial pressure (MAP) \<65mmHg for ≥ 1min, measures using the Acumen IQ sensor and Hemosphere monitor.

  Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

Secondary Outcomes (5)

• Incidence of hypotension

  Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

• Time spent in hypotension

  Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

• Choice of therapy (fluids/medications)

  Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation

• Dose of therapy (fluids/medications)

  Intraoperatively, starting 15 minutes after anesthesia induction.

• Protocol deviations

  Intraoperatively, starting 15 minutes after anesthesia induction

Study Arms (2)

HPI/AFM - Goal- Directed Hemodynamic Therapy

EXPERIMENTAL

Participants will receive goal-directed hemodynamic therapy guided by the Hypotension Prediction Index and Assisted Fluid Management software, using the Hemosphere monitor. Interventions include protocol-guided fluid and vasopressors to prevent or treat intraoperative hypotension.

Device: Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software

Conventional therapy

ACTIVE COMPARATOR

Participants will receive conventional hemodynamic intraoperative management based on anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed but Hypotension Prediction Index and Assisted Fluid Management outputs will not be visible to the anesthesiologist.

Other: Conventional Intraoperative Hemodynamic management

Interventions

Conventional Intraoperative Hemodynamic management OTHER

Participants receive hemodynamic management based on the anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed , but HPI and AFM outputs are not visible to the clinician.

Conventional therapy

Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software DEVICE

The Acumen IQ sensor will be used with the Hemosphere monitor to guide goal-directed hemodynamic therapy. HPI predicts impending hypotension and AFM guides fluid administration. Clinicians will follow a protocol algorithm to prevent or treat intraoperative hypotension with fluids, vasopressors or inotropes.

HPI/AFM - Goal- Directed Hemodynamic Therapy

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
• Intraoperative monitoring \> 2 hours or general anesthesia \> 2 hours
• Invasive arterial pressure monitoring
• Target MAP ≥ 65 mm Hg intraoperatively
• Written informed consent preoperatively
• ASA Physical Status ≤ 4

You may not qualify if:

• Target MAP other than 65 mm Hg
• Severe preoperative hypotension (MAP \< 65 mm Hg)
• Severe heart failure (e.g. LVEF \< 20%)
• Emergency surgery

Sponsors & Collaborators

• Attikon Hospital: collaborator
• National and Kapodistrian University of Athens: lead

Study Sites (1)

2nd University Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (22)

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• Joosten A, Alexander B, Delaporte A, Lilot M, Rinehart J, Cannesson M. Perioperative goal directed therapy using automated closed-loop fluid management: the future? Anaesthesiol Intensive Ther. 2015;47(5):517-23. doi: 10.5603/AIT.a2015.0069. Epub 2015 Nov 18.

  PMID: 26578397 RESULT

• Maheshwari K, Malhotra G, Bao X, Lahsaei P, Hand WR, Fleming NW, Ramsingh D, Treggiari MM, Sessler DI, Miller TE; Assisted Fluid Management Study Team. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. Anesthesiology. 2021 Aug 1;135(2):273-283. doi: 10.1097/ALN.0000000000003790.

  PMID: 33901281 RESULT

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  PMID: 29779129 RESULT

• Schuurmans J, Rellum SR, Schenk J, van der Ster BJP, van der Ven WH, Geerts BF, Hollmann MW, Cherpanath TGV, Lagrand WK, Wynandts PR, Paulus F, Driessen AHG, Terwindt LE, Eberl S, Hermanns H, Veelo DP, Vlaar APJ. Effect of a Machine Learning-Derived Early Warning Tool With Treatment Protocol on Hypotension During Cardiac Surgery and ICU Stay: The Hypotension Prediction 2 (HYPE-2) Randomized Clinical Trial. Crit Care Med. 2025 Feb 1;53(2):e328-e340. doi: 10.1097/CCM.0000000000006518. Epub 2024 Nov 22.

  PMID: 39576150 RESULT

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MeSH Terms

Interventions

Health Records, Personal; Microscopy, Atomic Force

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Microscopy, Scanning Probe; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Georgia Ntalamagka, MD

  Attikon Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Ntalamagka, MD

CONTACT

+306978210163; geo.dalamaga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Clinicians managing patients are aware of group assignment, as treatment decisions depend on the intervention. Outcome assessors collect data but do not influence group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two study groups. One group will receive goal-directed hemodynamic therapy using the Hypotension Prediction Index and Assisted Fluid Management software. The control group will receive conventional intraoperative hemodynamic management. Each participant will remain in the assigned group for the duration of the study without crossover.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 24, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)