Trial Outcomes & Findings for Hypotension Prediction Index (HPI) SMART-BP Trial (NCT NCT05105477)
NCT ID: NCT05105477
Last Updated: 2024-03-25
Results Overview
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
407 participants
Primary outcome timeframe
From post non-cardiac surgery to 30 days.
Results posted on
2024-03-25
Participant Flow
At the time of study termination, 407 subjects were enrolled, which included 369 pivotal subjects. Data from the pilot subjects were not analyzed for study outcomes. Only 369 subjects were pivotal subjects that were analyzed for study outcomes. The tables below display the information and results from the 369 pivotal subjects.
Participant milestones
| Measure |
HPI Arm
Acumen HPI Software Feature: The Acumen HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
|
Non-HPI Arm
Non-protocolized standard of care management per clinician and provider judgement
|
|---|---|---|
|
Overall Study
STARTED
|
187
|
182
|
|
Overall Study
COMPLETED
|
157
|
159
|
|
Overall Study
NOT COMPLETED
|
30
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypotension Prediction Index (HPI) SMART-BP Trial
Baseline characteristics by cohort
| Measure |
HPI Arm
n=187 Participants
Acumen HPI Software Feature: The Acumen HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
|
Non-HPI Arm
n=182 Participants
Non-protocolized standard of care management per clinician and provider judgement
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined to identify
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
150 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
187 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From post non-cardiac surgery to 30 days.A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Outcome measures
| Measure |
HPI Arm
n=157 Participants
Acumen HPI Software Feature: The Acumen HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
|
Non-HPI Arm
n=159 Participants
Non-protocolized standard of care management per clinician and provider judgement
|
|---|---|---|
|
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
|
19 participants with post-op complications
|
19 participants with post-op complications
|
Adverse Events
HPI Arm
Serious events: 48 serious events
Other events: 19 other events
Deaths: 3 deaths
Non-HPI Arm
Serious events: 38 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HPI Arm
n=187 participants at risk
Acumen HPI Software Feature: The Acumen HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
|
Non-HPI Arm
n=182 participants at risk
Non-protocolized standard of care management per clinician and provider judgement
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
6/187 • Number of events 6 • 30 days
|
1.6%
3/182 • Number of events 3 • 30 days
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
3/187 • Number of events 3 • 30 days
|
1.6%
3/182 • Number of events 3 • 30 days
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/187 • 30 days
|
1.1%
2/182 • Number of events 2 • 30 days
|
|
Cardiac disorders
Tachycardia
|
1.1%
2/187 • Number of events 2 • 30 days
|
0.00%
0/182 • 30 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Ileus Paralytic
|
1.6%
3/187 • Number of events 3 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Intra-Abdominal Fluid Collection
|
1.1%
2/187 • Number of events 2 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Melena
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Gastrointestinal disorders
Unknown Cause Of Nausea
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Gastrointestinal disorders
Pneumatosis Intestinalis
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Unknown Cause Of Vomiting
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Other
|
0.53%
1/187 • Number of events 1 • 30 days
|
2.2%
4/182 • Number of events 4 • 30 days
|
|
General disorders
Pyrexia
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Hepatobiliary disorders
Other
|
1.1%
2/187 • Number of events 2 • 30 days
|
0.00%
0/182 • 30 days
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/187 • 30 days
|
1.6%
3/182 • Number of events 3 • 30 days
|
|
Infections and infestations
Abscess
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Infections and infestations
Cellulitis
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.53%
1/187 • Number of events 1 • 30 days
|
1.1%
2/182 • Number of events 2 • 30 days
|
|
Infections and infestations
Sepsis
|
1.6%
3/187 • Number of events 3 • 30 days
|
1.6%
3/182 • Number of events 3 • 30 days
|
|
Infections and infestations
Wound Infection
|
1.1%
2/187 • Number of events 2 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Infections and infestations
Viral Infection
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Infections and infestations
Other
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Injury, poisoning and procedural complications
Mental Status Changes Postoperative
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural Hemorrhage
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Other
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Investigations
Troponin Increased
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Acidosis
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Nervous system disorders
Encephalopathy
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Nervous system disorders
Other
|
1.1%
2/187 • Number of events 3 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Psychiatric disorders
Mental Status Changes
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
4/187 • Number of events 4 • 30 days
|
6.6%
12/182 • Number of events 12 • 30 days
|
|
Renal and urinary disorders
Other
|
1.6%
3/187 • Number of events 3 • 30 days
|
0.00%
0/182 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.1%
2/187 • Number of events 2 • 30 days
|
3.3%
6/182 • Number of events 6 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/187 • 30 days
|
1.6%
3/182 • Number of events 3 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.53%
1/187 • Number of events 1 • 30 days
|
1.1%
2/182 • Number of events 2 • 30 days
|
|
Surgical and medical procedures
Abdominal Cavity Drainage
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Surgical and medical procedures
Other
|
1.1%
2/187 • Number of events 2 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Vascular disorders
Distributive Shock
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Vascular disorders
Shock Hemorrhagic
|
0.00%
0/187 • 30 days
|
0.55%
1/182 • Number of events 1 • 30 days
|
|
Vascular disorders
Other
|
1.6%
3/187 • Number of events 3 • 30 days
|
1.1%
2/182 • Number of events 2 • 30 days
|
|
Immune system disorders
Other
|
0.53%
1/187 • Number of events 1 • 30 days
|
0.00%
0/182 • 30 days
|
Other adverse events
| Measure |
HPI Arm
n=187 participants at risk
Acumen HPI Software Feature: The Acumen HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
|
Non-HPI Arm
n=182 participants at risk
Non-protocolized standard of care management per clinician and provider judgement
|
|---|---|---|
|
Investigations
Troponin Increased
|
10.2%
19/187 • Number of events 20 • 30 days
|
11.5%
21/182 • Number of events 21 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place