Moderate to High-risk Noncardiac SurgeryNCT05105477
Hypotension Prediction Index (HPI) SMART-BP Trial
A study testing AcumenTM HPI Software Feature in people with Moderate to High-risk Noncardiac Surgery, run by Edwards Lifesciences at 11 sites in United States.
Trial summary
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to High-risk Noncardiac Surgery
- What is being tested?
- AcumenTM HPI Software Feature
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Nov 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent
- Age >18 years
- ASA Physical Status > 2
- Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
- Planned blood pressure monitoring with an arterial line catheter;
- General anesthesia;
Who cannot join
- Participating in another interventional Trial;
- Contraindication to arterial blood pressure monitoring;
- Subjects with a physical site area too limited for proper Sensor placement
- Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
- Scheduled for intracranial surgery with permissive hypotension;
- Patient who is confirmed to be pregnant and/or nursing mothers;
Show all 12Show fewer
- Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
- Emergency surgery;
- Require beach-chair positioning;
- Scheduled for cardiac surgeries
- Have previously participated in the SMART-BP trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Michigan Medical Health System
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 97239
UT Southwestern
Dallas, Texas, 75235
Henry Ford Health System
Detroit, Michigan, 48202
Columbia University
New York, New York, 10032
Oregon Health & Science University
Portland, Oregon, 997239
UC Davis Medical Center
Sacramento, California, 95817
University of Washington
Seattle, Washington, 98195
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
- Conditions
- Moderate to High-risk Noncardiac Surgery
- Being tested
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcumenTM HPI Software FeatureDevice
The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
Non-protocolized Standard of CareOther
Non-protocolized standard of care to treat subjects
| Study group | Role | What they receive |
|---|---|---|
| HPI Arm | Experimental | AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. Receives: Device: AcumenTM HPI Software Feature |
| Non-HPI arm | Placebo comparator | Non-protocolized standard of care management per clinician and provider judgement Receives: Other: Non-protocolized Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Measured: From post non-cardiac surgery to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start17 Nov 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Why it stopped: Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to High-risk Noncardiac SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105477
- Sponsor's protocol ID
- 2021-04
- Status last verified
- Mar 2024
- First submitted
- 22 Oct 2021
- Last updated
- 25 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)
- ClinicalTrials.gov ID
- NCT05105477
- Acronym / sponsor ID
- 2021-04
- Conditions
- Moderate to High-risk Noncardiac Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPI Arm | Experimental | Device: AcumenTM HPI Software FeatureAcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. |
| Non-HPI arm | Placebo comparator | Other: Non-protocolized Standard of CareNon-protocolized standard of care management per clinician and provider judgement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Age >18 years
- ASA Physical Status > 2
- Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
- Planned blood pressure monitoring with an arterial line catheter;
Key exclusion criteria (12 listed)
- Participating in another interventional Trial;
- Contraindication to arterial blood pressure monitoring;
- Subjects with a physical site area too limited for proper Sensor placement
- Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
- Scheduled for intracranial surgery with permissive hypotension;
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 |
|---|---|---|
| AcumenTM HPI Software FeatureThe AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor. | Device | HPI Arm |
| Non-protocolized Standard of CareNon-protocolized standard of care to treat subjects | Other | Non-HPI arm |
Primary outcome
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
Time frame: From post non-cardiac surgery to 30 days.
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Moderate to High-risk Noncardiac Surgery
RecruitingPhase 4
The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium
Postoperative Delirium, Major Noncardiac Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcumenTM HPI Software Feature in people with Moderate to High-risk Noncardiac Surgery, 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Mar 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications. (time frame: From post non-cardiac surgery to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2024.