SMART TRENDS Study
Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery.
1 other identifier
interventional
296
1 country
8
Brief Summary
A multicenter, interventional, feasibility comparison with historical controls
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2023
CompletedFirst Submitted
Initial submission to the registry
July 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2025
CompletedDecember 22, 2025
October 1, 2025
2.3 years
July 14, 2023
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
HPI Smart Alert
The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm.
From start to end of non-cardiac surgery
Study Arms (2)
SMART TRENDS - Acumen IQ Sensor
OTHERAcumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
SMART TRENDS - Acumen IQ Cuff
OTHERAcumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
Interventions
Device: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor.
Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Age ≥ 18 years
- ASA Physical Status ≥ 2
- Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
- Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
- General anesthesia with tracheal intubation and positive pressure ventilation
You may not qualify if:
- Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors
- Planned vasopressor or inotrope infusion during surgery
- Contraindication to intra-arterial blood pressure monitoring
- Has previously participated in the SMART TRENDS study
- Serum creatine \> 2.0 mg/dL (\> 175 μmol/L) or CKD stage \> 3A
- Scheduled for intracranial or cardiac surgery
- Patient who is known to be pregnant
- Patients on mechanical circulatory support
- Emergency surgery
- Planned beach-chair positioning
- Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
- Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
- Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
UC Davis Medical Center
Sacramento, California, 95817, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Duke University
Durham, North Carolina, 27705, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Oregon Health & Science University
Portland, Oregon, 997239, United States
Prisma Health
Greenville, South Carolina, 29615, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Guerra-Londono CE, Hand WR, Fleming N, Davis J, Treggiari MM, Dunkman WJ, Kumar SS, Khanna AK, Yang JT, Domino KB. Hypotension prediction index smart alerts and trends to improve compliance with goal-directed hemodynamic therapy: a feasibility study. BMC Anesthesiol. 2025 Sep 30;25(1):471. doi: 10.1186/s12871-025-03336-z.
PMID: 41029588DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2023
First Posted
July 24, 2023
Study Start
July 11, 2023
Primary Completion
October 27, 2025
Study Completion
October 27, 2025
Last Updated
December 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share