HypotensionNCT03805217
Hypotension Prediction Index Study (HPI Study)
An observational study of Hypotension, run by Edwards Lifesciences at 11 sites in United States.
Trial summary
A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
- Type of treatment
- Medical device
- How many people
- 485 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 May 2019to 17 Mar 2020
- Phase
- Observational
- 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
Study population: Subjects recruited and enrolled should be classified as American Society of Anesthesiologist (ASA) physical status 3-4 who are scheduled for moderate-to-high-risk non-cardiac surgery and will be receiving pressure monitoring with an arterial line. Potentially qualifying patients will be evaluated during their preoperative anesthesia clinic visits.
Who may be able to join
- Written informed consent;
- Age ≥ 18 years;
- ASA Physical Status 3 or 4;
- Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
- Planned pressure monitoring with an arterial line;
- General anesthesia;
- Surgery duration expected to last ≥ 3 hours from induction;
- Planned overnight hospitalization.
Who cannot join
- Participating in another (interventional) study;
- Contraindication to the invasive blood pressure monitoring;
- Patient who is confirmed to be pregnant and/or nursing mothers;
- Emergency surgery;
- Known clinically important intra-cardiac shunts;
- Patient in whom an intraoperative MAP target will be < 65 mmHg;
Show all 18Show fewer
- Known aortic stenosis with valve area ≤ 1.5 cm2;
- Known moderate to severe aortic regurgitation;
- Known moderate to severe mitral regurgitation;
- Known moderate to severe mitral stenosis;
- Patient or surgical procedure type known as an SVV limitation (5) (e.g. tidal volume <8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio <3.6);
- Current persistent atrial fibrillation;
- Known acute congestive heart failure;
- Craniotomy;
- Surgery duration expected to last < 3 hours;
- Burn surgeries;
- Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 97239
Henry Ford Health System
Detroit, Michigan, 48202
Yale University
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
University of Washington
Seattle, Washington, 98195
Stanford Health Care
Stanford, California, 94305
About this study
Official title: Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software
A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)
- Conditions
- Hypotension
- Being tested
- EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature SoftwareDevice
EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Intraoperative Hypotension
Duration (t [min]) reduction of intraoperative hypotension (defined as MAP < 65 mmHg for at least 1 minute) as compared with a historic retrospective control group
Measured: Duration of Surgery
Secondary outcomes (1)
Intraoperative Hypotension in Each Subject
The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum.
Measured: Duration of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start16 May 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Abdelnour, MS, BSN, Study director, Edwards Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805217
- Sponsor's protocol ID
- 2018-15
- Status last verified
- Aug 2020
- First submitted
- 14 Jan 2019
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bao X, Kumar SS, Shah NJ, Penning D, Weinstein M, Malhotra G, Rose S, Drover D, Pennington MW, Domino K, Meng L, Treggiari M, Clavijo C, Wagener G, Chitilian H, Maheshwari K; HPI Study Team. AcumenTM hypotension prediction index guidance for prevention and treatment of hypotension in noncardiac surgery: a prospective, single-arm, multicenter trial. Perioper Med (Lond). 2024 Mar 4;13(1):13. doi: 10.1186/s13741-024-00369-9.
PubMed 38439069
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software
- ClinicalTrials.gov ID
- NCT03805217
- Acronym / sponsor ID
- 2018-15
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 15 Jan 2019 (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.
A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects recruited and enrolled should be classified as American Society of Anesthesiologist (ASA) physical status 3-4 who are scheduled for moderate-to-high-risk non-cardiac surgery and will be receiving pressure monitoring with an arterial line. Potentially qualifying patients will be evaluated during their preoperative anesthesia clinic visits.
Key inclusion criteria (8 listed)
- Written informed consent;
- Age ≥ 18 years;
- ASA Physical Status 3 or 4;
- Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
- Planned pressure monitoring with an arterial line;
Key exclusion criteria (18 listed)
- Participating in another (interventional) study;
- Contraindication to the invasive blood pressure monitoring;
- Patient who is confirmed to be pregnant and/or nursing mothers;
- Emergency surgery;
- Known clinically important intra-cardiac shunts;
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 |
|---|---|---|
| EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature SoftwareEV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software | Device | – |
Primary outcome
Reduction of Intraoperative Hypotension
Time frame: Duration of Surgery
Duration (t [min]) reduction of intraoperative hypotension (defined as MAP < 65 mmHg for at least 1 minute) as compared with a historic retrospective control group
1 secondary outcome
Intraoperative Hypotension in Each Subject
Time frame: Duration of Surgery
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 18 Oct 2024.
- Derived from this study: PubMed 38439069Bao X, Kumar SS, Shah NJ, Penning D, Weinstein M, Malhotra G, Rose S, Drover D, Pennington MW, Domino K, Meng L, Treggiari M, Clavijo C, Wagener G, Chitilian H, Maheshwari K; HPI Study Team. AcumenTM hypotension prediction index guidance for prevention and treatment of hypotension in noncardiac surgery: a prospective, single-arm, multicenter trial. Perioper Med (Lond). 2024 Mar 4;13(1):13. doi: 10.1186/s13741-024-00369-9.
- 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. This study is not recruiting at the moment.
Tina Abdelnour, MS, BSN study director
Edwards Lifesciences
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by Edwards Lifesciences at 11 sites in United States.
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 8 inclusion and 18 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Reduction of Intraoperative Hypotension (time frame: Duration of Surgery). 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 NCT03805217, which also lists 1 linked publication.
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 18 Oct 2024.