Intraoperative HypotensionHYPE-2NCT05821647

Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission

A study testing HPI guided treatment advice in people with Intraoperative Hypotension and Postoperative Hypotension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial registration serves as an amendment incorporating the IPD Sharing Statement. This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intraoperative Hypotension, Postoperative Hypotension, Hypotension
What is being tested?: HPI guided treatment advice
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteNetherlands
Study dates: 20 May 2021to 16 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

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

Aged 18 years or older at inclusion
Planned for elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement)
Planned to receive standard monitoring for cardiac surgery
Target MAP of 65 mmHg or above during surgery
Target MAP of 65 mmHg or above during the mechanically ventilated phase of ICU admission

Who cannot join

Known cardiac shunts (significant)
Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery)
Expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery
Dialysis dependent kidney failure prior to surgery
Planned to receive Perioperative Goal Directed Therapy (PGDT) other than standard intraoperative care
Previous cardiac surgery in medical history

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Amsterdam University Medical Centers
Amsterdam-Zuidoost, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: Effect of a Machine Learning-Derived Early Warning System for Hypotension vs Standard Care on Depth and Duration of Intra- and Postoperative Hypotension in Elective Cardiac Surgery

This trial registration serves as an amendment incorporating the IPD Sharing Statement.

This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. This means that existing registrations are still visible, but can no longer be adjusted.

Study summary:

Hypotension in the operating room (OR) and during post-operative ICU admission is common in surgical patients and even more prevalent in cardiac surgery patients. It is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. Edwards Lifesciences (Irvine, CA) has developed the Hypotension Prediction Index (HPI), an early warning system that predicts an hypotensive event, defined as MAP below 65 mmHg, with high accuracy minutes before it occurs. At the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or ICU admitted patients. The aim of the HYPE-2 trial is to assess whether the HPI-algorithm can reduce the time-weighted average (TWA) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (CABG) surgery patients.

Read the detailed description

Population studied:

All adult patients undergoing elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement), requiring a radial arterial line and an intended target MAP of 65 mmHg or above during both surgery (excluding cardiopulmonary bypass pump time (CBP)) and during mechanically ventilated phase of duration of ICU admission.

Conditions: Intraoperative Hypotension, Postoperative Hypotension, Hypotension
Being tested: HPI guided treatment advice
Keywords: Intensive Care Unit, Cardiac surgery, Coronary Artery Bypass Grafting
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 treatment adviceOther
Administer hemodynamic altering intervention aimed at either a preload, contractility, or afterload problem to prevent impending hypotension. Treatment options include: administering either fluids, inotropes, vasopressors, positional changes, or a combination.

Study groups in NCT05821647
Study group	Role	What they receive
Control group	No intervention	Objective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution. This is done using standard hemodynamic monitoring, which in our center consists of continuous arterial blood pressure monitoring and the pulse pressure variation parameter. The clinician will administer either fluids, inotropes, vasopressors, or a combination, or apply positional changes to maintain the set MAP threshold.
Additional HPI guided treatment	Experimental	Objective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution. This is done using standard hemodynamic monitoring (as described for the control group) but is assisted by the Hypotension Prediction Index (HPI). This parameter is made available to the clinicians with the HemoSphere Advanced Monitoring Platform (HemoSphere) and is used to initiate treatment when the HPI values is ≥ 75. It also provides additional advanced hemodynamic variables (e.g. cardiac output, systemic vascular resistance). The treating clinicians are trained to use these variables and are provided with a diagnostic flowchart to determine the cause (preload, contractility and afterload) of the upcoming hypotensive (MAP < 65 mmHg) event. Timing of treatment and choice of treatment is then left to the discretion of the attending clinician. Receives: Other: HPI guided treatment advice

What is being measured

The primary outcome is the main question the study is designed to answer.

The overall time-weighted average (TWA) of hypotension (severity of hypotension)
TWA is a calculation of the depth (in mmHg) of hypotension below the 'threshold' MAP of 65 mmHg x the time spent in hypotension in minutes, this resulting in an 'area'. To better compare this value between different patients the 'area' can be divided by the total duration of the measurement.
Measured: During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

Secondary outcomes (18)

Incidence of hypotension
number of hypotensive events during study phases
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time spent in hypotension
amount of time in minutes spent in hypotension during study phases
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The percentage of time in hypotension
amount of time in hypotension expressed in percentage of the total study phases' duration
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The AUT of a MAP < 65 mmHg
AUT is a calculation of the depth (in mmHg) of hypotension below the 'threshold' MAP of 65 mmHg x the time spent in hypotension in minutes, this resulting in an 'area'.
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Incidence of hypertension
number of hypertensive events during study phases
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time spent in hypertension
amount of time in minutes spent in hypertension during study phases
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The percentage of time in hypertension
amount of time in hypertension expressed in percentage of the total study phases' duration
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The AAT of a MAP > 100 mmHg
AAT is a calculation of the depth (in mmHg) of hypertension above the 'threshold' MAP of 100 mmHg x the time spent in hypertension in minutes, this resulting in an 'area'.
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
TWA of hypertension
TWA is a calculation of the depth (in mmHg) of hypertension above the 'threshold' MAP of 100 mmHg x the time spent in hypertension in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Incidence of HPI alarm (HPI ≥ 75)
number of HPI alarms during study phases
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time spent in HPI alarm
amount of time in minutes spent in HPI alarms during study phases
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The percentage of time in HPI alarm
amount of time in HPI alarms expressed in percentage of the total study phases' duration
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The AAT of a HPI ≥ 75
AAT is a calculation of the depth of HPI above or equal to the 'threshold' of 75 x the time spent in HPI alarm in minutes, this resulting in an 'area'.
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
TWA of HPI alarm
TWA is a calculation of the depth of HPI above or equal to the 'threshold' of 75 x the time spent in HPI alarm in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Treatment choice
vasopressors, blood transfusions, fluids, inotropes, position changes, decrease in anesthetics
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Treatment dose
Dosage of medication or volume of fluids
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time to treatment
If an alarm or hypotensive event had more than 1 treatment, the time to first treatment will be used.
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Number of treatments
amount of treatments (e.g., administered fluids, vasopressors, inotropes, anesthetics) given to alter the hemodynamics (increase of reduce the blood pressure)
Measured: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202116 Mar 2023

First posted20 Apr 2023
Study start20 May 2021
Primary completion16 Feb 2023
Study completion16 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study has two arms in which patients are allocated in a 1:1 randomization ratio.
Masking: Single blind
Who is masked: Participant
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05821647
Sponsor's protocol ID: NL76236.018.21
Other IDs: NL9449
Acronym: HYPE-2
Status last verified: Apr 2023
First submitted: 28 Feb 2023
Last updated: 20 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in the final article including results in the text, tables, figures, and appendices, will be made available after deidentification.

Publications

Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
PubMed 32065827
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.
PubMed 29894315
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.
PubMed 39576150
Rellum SR, Schuurmans J, Schenk J, van der Ster BJP, van der Ven WH, Geerts BF, Hollmann MW, Cherpanath TGV, Lagrand WK, Wynandts P, Paulus F, Driessen AHG, Terwindt LE, Eberl S, Hermanns H, Veelo DP, Vlaar APJ. Effect of the machine learning-derived Hypotension Prediction Index (HPI) combined with diagnostic guidance versus standard care on depth and duration of intraoperative and postoperative hypotension in elective cardiac surgery patients: HYPE-2 - study protocol of a randomised clinical trial. BMJ Open. 2023 May 2;13(5):e061832. doi: 10.1136/bmjopen-2022-061832.
PubMed 37130670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intraoperative Hypotension trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Machine Learning-Derived Early Warning System for Hypotension vs Standard Care on Depth and Duration of Intra- and Postoperative Hypotension in Elective Cardiac Surgery
ClinicalTrials.gov ID: NCT05821647
Acronym / sponsor ID: HYPE-2 / NL76236.018.21
Conditions: Intraoperative Hypotension, Postoperative Hypotension, Hypotension
Keywords: Intensive Care Unit, Cardiac surgery, Coronary Artery Bypass Grafting
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
Collaborators: Edwards Lifesciences
Study start: 20 May 2021 (actual)
Primary completion: 16 Feb 2023 (actual)
Study completion: 16 Mar 2023 (actual)
First posted: 20 Apr 2023 (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 trial registration serves as an amendment incorporating the IPD Sharing Statement.

Study summary:

Detailed description

Population studied:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The study has two arms in which patients are allocated in a 1:1 randomization ratio.

Arm	Type	Receives
Control group	No intervention	–Objective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution. This is done using standard hemodynamic monitoring, which in our center consists of continuous arterial blood pressure monitoring and the pulse pressure variation parameter. The clinician will administer either fluids, inotropes, vasopressors, or a combination, or apply positional changes to maintain the set MAP threshold.
Additional HPI guided treatment	Experimental	Other: HPI guided treatment adviceObjective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution. This is done using standard hemodynamic monitoring (as described for the control group) but is assisted by the Hypotension Prediction Index (HPI). This parameter is made available to the clinicians with the HemoSphere Advanced Monitoring Platform (HemoSphere) and is used to initiate treatment when the HPI values is ≥ 75. It also provides additional advanced hemodynamic variables (e.g. cardiac output, systemic vascular resistance). The treating clinicians are trained to use these variables and are provided with a diagnostic flowchart to determine the cause (preload, contractility and afterload) of the upcoming hypotensive (MAP < 65 mmHg) event. Timing of treatment and choice of treatment is then left to the discretion of the attending clinician.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged 18 years or older at inclusion
Planned for elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement)
Planned to receive standard monitoring for cardiac surgery
Target MAP of 65 mmHg or above during surgery
Target MAP of 65 mmHg or above during the mechanically ventilated phase of ICU admission

Key exclusion criteria (6 listed)

Known cardiac shunts (significant)
Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery)
Expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery
Dialysis dependent kidney failure prior to surgery
Planned to receive Perioperative Goal Directed Therapy (PGDT) other than standard intraoperative care

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
HPI guided treatment adviceAdminister hemodynamic altering intervention aimed at either a preload, contractility, or afterload problem to prevent impending hypotension. Treatment options include: administering either fluids, inotropes, vasopressors, positional changes, or a combination.	Other	Additional HPI guided treatment

Primary outcome

The overall time-weighted average (TWA) of hypotension (severity of hypotension)
Time frame: During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
TWA is a calculation of the depth (in mmHg) of hypotension below the 'threshold' MAP of 65 mmHg x the time spent in hypotension in minutes, this resulting in an 'area'. To better compare this value between different patients the 'area' can be divided by the total duration of the measurement.

18 secondary outcomes

Incidence of hypotension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time spent in hypotension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The percentage of time in hypotension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The AUT of a MAP < 65 mmHg
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Incidence of hypertension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time spent in hypertension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The percentage of time in hypertension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The AAT of a MAP > 100 mmHg
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
TWA of hypertension
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Incidence of HPI alarm (HPI ≥ 75)
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time spent in HPI alarm
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The percentage of time in HPI alarm
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
The AAT of a HPI ≥ 75
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
TWA of HPI alarm
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Treatment choice
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Treatment dose
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Time to treatment
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Number of treatments
Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
Background: PubMed 32065827Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
Background: PubMed 29894315Hatib 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.
Derived from this study: 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.
Derived from this study: PubMed 37130670Rellum SR, Schuurmans J, Schenk J, van der Ster BJP, van der Ven WH, Geerts BF, Hollmann MW, Cherpanath TGV, Lagrand WK, Wynandts P, Paulus F, Driessen AHG, Terwindt LE, Eberl S, Hermanns H, Veelo DP, Vlaar APJ. Effect of the machine learning-derived Hypotension Prediction Index (HPI) combined with diagnostic guidance versus standard care on depth and duration of intraoperative and postoperative hypotension in elective cardiac surgery patients: HYPE-2 - study protocol of a randomised clinical trial. BMJ Open. 2023 May 2;13(5):e061832. doi: 10.1136/bmjopen-2022-061832.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the final article including results in the text, tables, figures, and appendices, will be made available after deidentification.

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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. This study is not recruiting at the moment.

A.P.J. Vlaar principal investigator

Department of Intensive Care, Amsterdam UMC, location AMC, Amsterdam, the Netherlands

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 20 Apr 2023. 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 Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The overall time-weighted average (TWA) of hypotension (severity of hypotension) (time frame: During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)). 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 NCT05821647, which also lists 4 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 2023.