Intraoperative HypotensionNCT07301307
Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia
A study testing Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software and Conventional Intraoperative Hemodynamic management in people with Intraoperative Hypotension, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software and Conventional Intraoperative Hemodynamic management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 15 Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Target MAP other than 65 mm Hg
- Severe preoperative hypotension (MAP < 65 mm Hg)
- Severe heart failure (e.g. LVEF < 20%)
- Emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
2nd University Department of Anesthesiology, Attikon University Hospital
Athens, Attica, 12462
Georgia Ntalamagka, +306978210163, geo.dalamaga@gmail.com
About this study
Official title: The Use of the Hypotension Prediction Index (HPI) Combined With the Assisted Fluid Management (AFM) Software for Perioperative Hemodynamic Optimization in Patients Undergoing General Anesthesia.
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.
Read the detailed description
Intraoperative hypotension is a common complication during general anesthesia and is associated with an increased risk of postoperative organ dysfunction (acute kidney injury, myocardial ischemia). Even short episodes of mean arterial pressure (MAP) below accepted thresholds have been shown to adversely affect patient outcomes.
The Hypotension Prediction Index , (HPI)is a software that predicts the likelihood of hypotension minutes before it occurs, based on the arterial waveform. Thus clinicians have the opportunity to identify patients at risk of hypotension and intervene early.
The Assisted Fluid Management (AFM) software is designed to optimize perioperative fluid administration based on the Frank-Starling curve. The AFM provides guidance on crystalloid admininistration only when it is expected to increase stroke volume and cardiac output.
This prospective , randomized study evaluates whether the use of HPI coupled with AFM within a goal directed hemodynamic protocol improves perioperative hemodynamic management and reduces the incidence and duration of adult patients undergoing surgery under general anesthesia.
A total of 100 adult patients will be enrolled , for elective surgery with invasive blood pressure monitoring and intraoperative mean arterial pressure target of at least 65 mm Hg.
Patients in the intervention group will undergo goal directed hemodynamic management guided by HPI and AFM algorithms via the Hemosphere monitor and Acumen IQ sensor. The AFM software will determine the timing of fluid administration. Elevated HPI values indicating impending hypotension will be managed in a targeted manner with fluids, vasopressors or inotropes.
Patients in the control group will receive conventional hemodynamic management , based on clinical judgement, in accordance with international guidelines. Although an Acumen IQ sensor will be placed, HPI and AFM indications will not be visible to the attending anesthesiologist and will not influence clinical decision making.
Intraoperative hemodynamic data will be continuously recorded in both groups. A member of the research team will be present to supervise the procedure. The primary outcome is the time-weighted average of hypotension, defined as MAP below 65 mm Hg for at least one minute. Secondary outcomes include the incidence and duration of hypotension, type and dose of administered therapies and protocol adherence.
- Conditions
- Intraoperative Hypotension
- Being tested
- Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software, Conventional Intraoperative Hemodynamic management
- Keywords
- Intraoperative Hypotension, Perioperative Hemodynamic Optimization, Goal-Directed Hemodynamic Therapy, Hypotension Prediction Index, Assisted Fluid Management, Invasive Arterial Pressure Monitoring, Artificial Intelligence, Perioperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) softwareDevice
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.
Conventional Intraoperative Hemodynamic managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Intraoperative Hemodynamic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Secondary outcomes (5)
Incidence of hypotension
Incidence of hypotension, defined as MAP <65mmHg for ≥ 1min.
Measured: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Time spent in hypotension
Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥ 1min
Measured: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Choice of therapy (fluids/medications)
Medication used to prevent/treat hypotension. A study member is present at the OR to make notes.
Measured: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Dose of therapy (fluids/medications)
Dose of medication used to prevent/treat hypotension.
Measured: Intraoperatively, starting 15 minutes after anesthesia induction.
Protocol deviations
Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Measured: Intraoperatively, starting 15 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Attikon Hospital
- Responsible party
- Principal investigator, NTALAMAGKA GEORGIA, Attikon Hospital
- Investigators
- Georgia Ntalamagka, MD, Principal investigator, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301307
- Sponsor's protocol ID
- 641/24-09-2025
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
20. Pinsky MR. Protocolized cardiovascular management based on ventricular-arterial coupling. In: Functional Hemodynamic Monitoring. Update in Intensive Care and Emergency Medicine. 2004, Springer-Verlag, Berlin, 381 - 395. ISBN 3540223495
Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
PubMed 25524443Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.
PubMed 27683581Coeckelenbergh S, Soucy-Proulx M, Van der Linden P, Roullet S, Moussa M, Kato H, Toubal L, Naili S, Rinehart J, Grogan T, Cannesson M, Duranteau J, Joosten A. Restrictive versus Decision Support Guided Fluid Therapy during Major Hepatic Resection Surgery: A Randomized Controlled Trial. Anesthesiology. 2024 Nov 1;141(5):881-890. doi: 10.1097/ALN.0000000000005175.
PubMed 39052844Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, Soucy-Proulx M, Alexander B, Rinehart J, Grogan T, Cannesson M, Vincent JL, Vicaut E, Duranteau J, Joosten A. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097.
PubMed 39116013Joosten A, Coeckelenbergh S, Delaporte A, Ickx B, Closset J, Roumeguere T, Barvais L, Van Obbergh L, Cannesson M, Rinehart J, Van der Linden P. Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching. Eur J Anaesthesiol. 2018 Sep;35(9):650-658. doi: 10.1097/EJA.0000000000000827.
PubMed 29750699Joosten 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.
PubMed 26578397Maheshwari 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.
PubMed 33901281Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.
PubMed 29779129Schuurmans 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.
PubMed 39576150Shin B, Maler SA, Reddy K, Fleming NW. Use of the Hypotension Prediction Index During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1769-1775. doi: 10.1053/j.jvca.2020.12.025. Epub 2020 Dec 21.
PubMed 33446404van der Ven WH, Terwindt LE, Risvanoglu N, Ie ELK, Wijnberge M, Veelo DP, Geerts BF, Vlaar APJ, van der Ster BJP. Performance of a machine-learning algorithm to predict hypotension in mechanically ventilated patients with COVID-19 admitted to the intensive care unit: a cohort study. J Clin Monit Comput. 2022 Oct;36(5):1397-1405. doi: 10.1007/s10877-021-00778-x. Epub 2021 Nov 13.
PubMed 34775533Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.
PubMed 32960954Murabito P, Astuto M, Sanfilippo F, La Via L, Vasile F, Basile F, Cappellani A, Longhitano L, Distefano A, Li Volti G. Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial. J Clin Med. 2022 Jan 13;11(2):392. doi: 10.3390/jcm11020392.
PubMed 35054083Tsoumpa M, Kyttari A, Matiatou S, Tzoufi M, Griva P, Pikoulis E, Riga M, Matsota P, Sidiropoulou T. The Use of the Hypotension Prediction Index Integrated in an Algorithm of Goal Directed Hemodynamic Treatment during Moderate and High-Risk Surgery. J Clin Med. 2021 Dec 15;10(24):5884. doi: 10.3390/jcm10245884.
PubMed 34945177
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Hypotension Prediction Index (HPI) Combined With the Assisted Fluid Management (AFM) Software for Perioperative Hemodynamic Optimization in Patients Undergoing General Anesthesia.
- ClinicalTrials.gov ID
- NCT07301307
- Acronym / sponsor ID
- 641/24-09-2025
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Attikon Hospital
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intraoperative hypotension is a common complication during general anesthesia and is associated with an increased risk of postoperative organ dysfunction (acute kidney injury, myocardial ischemia). Even short episodes of mean arterial pressure (MAP) below accepted thresholds have been shown to adversely affect patient outcomes.
The Hypotension Prediction Index , (HPI)is a software that predicts the likelihood of hypotension minutes before it occurs, based on the arterial waveform. Thus clinicians have the opportunity to identify patients at risk of hypotension and intervene early.
The Assisted Fluid Management (AFM) software is designed to optimize perioperative fluid administration based on the Frank-Starling curve. The AFM provides guidance on crystalloid admininistration only when it is expected to increase stroke volume and cardiac output.
This prospective , randomized study evaluates whether the use of HPI coupled with AFM within a goal directed hemodynamic protocol improves perioperative hemodynamic management and reduces the incidence and duration of adult patients undergoing surgery under general anesthesia.
A total of 100 adult patients will be enrolled , for elective surgery with invasive blood pressure monitoring and intraoperative mean arterial pressure target of at least 65 mm Hg.
Patients in the intervention group will undergo goal directed hemodynamic management guided by HPI and AFM algorithms via the Hemosphere monitor and Acumen IQ sensor. The AFM software will determine the timing of fluid administration. Elevated HPI values indicating impending hypotension will be managed in a targeted manner with fluids, vasopressors or inotropes.
Patients in the control group will receive conventional hemodynamic management , based on clinical judgement, in accordance with international guidelines. Although an Acumen IQ sensor will be placed, HPI and AFM indications will not be visible to the attending anesthesiologist and will not influence clinical decision making.
Intraoperative hemodynamic data will be continuously recorded in both groups. A member of the research team will be present to supervise the procedure. The primary outcome is the time-weighted average of hypotension, defined as MAP below 65 mm Hg for at least one minute. Secondary outcomes include the incidence and duration of hypotension, type and dose of administered therapies and protocol adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HPI/AFM - Goal- Directed Hemodynamic Therapy | Experimental | Device: Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) softwareParticipants 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. |
| Conventional therapy | Active comparator | Other: Conventional Intraoperative Hemodynamic managementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Target MAP other than 65 mm Hg
- Severe preoperative hypotension (MAP < 65 mm Hg)
- Severe heart failure (e.g. LVEF < 20%)
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) softwareThe 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. | Device | HPI/AFM - Goal- Directed Hemodynamic Therapy |
| Conventional Intraoperative Hemodynamic managementParticipants 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. | Other | Conventional therapy |
Primary outcome
Time-weighted average of intraoperative hypotension
Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Time weighted average spent in hypotension, defined as mean arterial pressure (MAP) <65mmHg for ≥ 1min, measures using the Acumen IQ sensor and Hemosphere monitor.
5 secondary outcomes
Incidence of hypotension
Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Time spent in hypotension
Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Choice of therapy (fluids/medications)
Time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Dose of therapy (fluids/medications)
Time frame: Intraoperatively, starting 15 minutes after anesthesia induction.
Protocol deviations
Time frame: Intraoperatively, starting 15 minutes after anesthesia induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication20. Pinsky MR. Protocolized cardiovascular management based on ventricular-arterial coupling. In: Functional Hemodynamic Monitoring. Update in Intensive Care and Emergency Medicine. 2004, Springer-Verlag, Berlin, 381 - 395. ISBN 3540223495
- Results publication: PubMed 25524443Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
- Results publication: PubMed 27683581Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.
- Results publication: PubMed 39052844Coeckelenbergh S, Soucy-Proulx M, Van der Linden P, Roullet S, Moussa M, Kato H, Toubal L, Naili S, Rinehart J, Grogan T, Cannesson M, Duranteau J, Joosten A. Restrictive versus Decision Support Guided Fluid Therapy during Major Hepatic Resection Surgery: A Randomized Controlled Trial. Anesthesiology. 2024 Nov 1;141(5):881-890. doi: 10.1097/ALN.0000000000005175.
- Results publication: PubMed 39116013Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, Soucy-Proulx M, Alexander B, Rinehart J, Grogan T, Cannesson M, Vincent JL, Vicaut E, Duranteau J, Joosten A. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097.
- Results publication: PubMed 29750699Joosten A, Coeckelenbergh S, Delaporte A, Ickx B, Closset J, Roumeguere T, Barvais L, Van Obbergh L, Cannesson M, Rinehart J, Van der Linden P. Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching. Eur J Anaesthesiol. 2018 Sep;35(9):650-658. doi: 10.1097/EJA.0000000000000827.
- Results publication: PubMed 26578397Joosten 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.
- Results publication: PubMed 33901281Maheshwari 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.
- Results publication: PubMed 29779129Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.
- Results publication: PubMed 39576150Schuurmans 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.
- Results publication: PubMed 33446404Shin B, Maler SA, Reddy K, Fleming NW. Use of the Hypotension Prediction Index During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1769-1775. doi: 10.1053/j.jvca.2020.12.025. Epub 2020 Dec 21.
- Results publication: PubMed 34775533van der Ven WH, Terwindt LE, Risvanoglu N, Ie ELK, Wijnberge M, Veelo DP, Geerts BF, Vlaar APJ, van der Ster BJP. Performance of a machine-learning algorithm to predict hypotension in mechanically ventilated patients with COVID-19 admitted to the intensive care unit: a cohort study. J Clin Monit Comput. 2022 Oct;36(5):1397-1405. doi: 10.1007/s10877-021-00778-x. Epub 2021 Nov 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgia Ntalamagka, MD principal investigator
Attikon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software and Conventional Intraoperative Hemodynamic management in people with Intraoperative Hypotension, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgia Ntalamagka, MD (+306978210163, geo.dalamaga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average of intraoperative hypotension (time frame: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07301307, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.