Trial Outcomes & Findings for HPI (Hypotension Prediction Index) Care Trial (NCT NCT05083403)
NCT ID: NCT05083403
Last Updated: 2026-06-10
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
From post-bypass procedure period to the first 8-hour ICU period (one day)
Results posted on
2026-06-10
Participant Flow
At the time of study termination, 170 participants were enrolled. A total of 152 participants were analyzed for study outcomes. 18 participants were not analyzed due to incomplete data collection.
Participant milestones
| Measure |
HPI Arm
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
AcumenTM HPI Software Feature: 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-HPI Arm
Non-protocolized standard of care management per clinician and provider judgement.
Non-protocolized Standard of Care: Non-protocolized standard of care to treat subjects
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
84
|
|
Overall Study
COMPLETED
|
76
|
78
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
HPI Arm
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
AcumenTM HPI Software Feature: 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-HPI Arm
Non-protocolized standard of care management per clinician and provider judgement.
Non-protocolized Standard of Care: Non-protocolized standard of care to treat subjects
|
|---|---|---|
|
Overall Study
Withdrawn by Investigator
|
9
|
6
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
HPI (Hypotension Prediction Index) Care Trial
Baseline characteristics by cohort
| Measure |
HPI Arm
n=86 Participants
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
AcumenTM HPI Software Feature: 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-HPI Arm
n=84 Participants
Non-protocolized standard of care management per clinician and provider judgement.
Non-protocolized Standard of Care: Non-protocolized standard of care to treat subjects
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 Years
n=9 Participants
|
66.3 Years
n=27 Participants
|
66.3 Years
n=267 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
53 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=9 Participants
|
58 Participants
n=27 Participants
|
117 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
9 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
74 Participants
n=9 Participants
|
76 Participants
n=27 Participants
|
150 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Declined to identify
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=9 Participants
|
84 Participants
n=27 Participants
|
170 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From post-bypass procedure period to the first 8-hour ICU period (one day)Outcome measures
| Measure |
HPI Arm
n=75 Participants
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
AcumenTM HPI Software Feature: 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-HPI Arm
n=77 Participants
Non-protocolized standard of care management per clinician and provider judgement.
Non-protocolized Standard of Care: Non-protocolized standard of care to treat subjects
|
|---|---|---|
|
Mean Duration of Hypotension (Defined as MAP < 65mmHg) in Minutes.
|
30.6 Minutes
Standard Deviation 35.30
|
41.6 Minutes
Standard Deviation 68.54
|
Adverse Events
HPI Arm
Serious events: 26 serious events
Other events: 31 other events
Deaths: 1 deaths
Non-HPI Arm
Serious events: 21 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HPI Arm
n=86 participants at risk
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
AcumenTM HPI Software Feature: 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-HPI Arm
n=84 participants at risk
Non-protocolized standard of care management per clinician and provider judgement.
Non-protocolized Standard of Care: Non-protocolized standard of care to treat subjects
|
|---|---|---|
|
Infections and infestations
Wound Infection
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Injury, poisoning and procedural complications
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Investigations
Acute Heart Failure
|
9.3%
8/86 • Number of events 8 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Nervous system disorders
Epilepsy
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Psychiatric disorders
Mental Status Changes
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Psychiatric disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.5%
3/86 • Number of events 3 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Renal and urinary disorders
Urinary Retention
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.5%
3/86 • Number of events 3 • 30 Days
|
3.6%
3/84 • Number of events 3 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.2%
1/86 • Number of events 1 • 30 Days
|
2.4%
2/84 • Number of events 2 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.7%
4/86 • Number of events 4 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Vascular disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Blood and lymphatic system disorders
Other
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Cardiac disorders
Arrhythmia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
6.0%
5/84 • Number of events 6 • 30 Days
|
|
Cardiac disorders
Atrial Fibrillation
|
3.5%
3/86 • Number of events 3 • 30 Days
|
7.1%
6/84 • Number of events 6 • 30 Days
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
1/86 • Number of events 3 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Cardiac disorders
Other
|
7.0%
6/86 • Number of events 7 • 30 Days
|
4.8%
4/84 • Number of events 4 • 30 Days
|
|
Cardiac disorders
Sinus Bradycardia
|
2.3%
2/86 • Number of events 2 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Cardiac disorders
Syncope
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
2/86 • Number of events 2 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Gastrointestinal disorders
Ileus Paralytic
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
General disorders
Other
|
2.3%
2/86 • Number of events 2 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
General disorders
Pyrexia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Infections and infestations
Pneumonia
|
2.3%
2/86 • Number of events 2 • 30 Days
|
3.6%
3/84 • Number of events 3 • 30 Days
|
|
Infections and infestations
Sepsis
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
Other adverse events
| Measure |
HPI Arm
n=86 participants at risk
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
AcumenTM HPI Software Feature: 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-HPI Arm
n=84 participants at risk
Non-protocolized standard of care management per clinician and provider judgement.
Non-protocolized Standard of Care: Non-protocolized standard of care to treat subjects
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.0%
12/86 • Number of events 13 • 30 Days
|
15.5%
13/84 • Number of events 14 • 30 Days
|
|
Blood and lymphatic system disorders
Other
|
2.3%
2/86 • Number of events 2 • 30 Days
|
4.8%
4/84 • Number of events 4 • 30 Days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
2/86 • Number of events 2 • 30 Days
|
3.6%
3/84 • Number of events 3 • 30 Days
|
|
Cardiac disorders
Arrhythmia
|
3.5%
3/86 • Number of events 3 • 30 Days
|
8.3%
7/84 • Number of events 7 • 30 Days
|
|
Cardiac disorders
Atrial Fibrillation
|
33.7%
29/86 • Number of events 30 • 30 Days
|
28.6%
24/84 • Number of events 24 • 30 Days
|
|
Cardiac disorders
Other
|
3.5%
3/86 • Number of events 3 • 30 Days
|
4.8%
4/84 • Number of events 4 • 30 Days
|
|
Cardiac disorders
Sinus Bradycardia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Cardiac disorders
Tachycardia
|
2.3%
2/86 • Number of events 2 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Eye disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Dysphagia
|
4.7%
4/86 • Number of events 4 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Gastrointestinal disorders
Hematochezia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Gastrointestinal disorders
Ileus Paralytic
|
8.1%
7/86 • Number of events 7 • 30 Days
|
4.8%
4/84 • Number of events 4 • 30 Days
|
|
Gastrointestinal disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Gastrointestinal disorders
Unknown Cause Of Nausea
|
4.7%
4/86 • Number of events 4 • 30 Days
|
3.6%
3/84 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Unknown Cause Of Vomiting
|
2.3%
2/86 • Number of events 2 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
General disorders
Edema
|
0.00%
0/86 • 30 Days
|
2.4%
2/84 • Number of events 2 • 30 Days
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
General disorders
Unkown Cause Of Pain
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Hepatobiliary disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Infections and infestations
Cellulitis
|
1.2%
1/86 • Number of events 1 • 30 Days
|
4.8%
4/84 • Number of events 4 • 30 Days
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Infections and infestations
Oral Candidiasis
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Infections and infestations
Pneumonia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Infections and infestations
Urinary Tract Infection
|
5.8%
5/86 • Number of events 5 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Infections and infestations
Wound Infection
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.2%
1/86 • Number of events 1 • 30 Days
|
2.4%
2/84 • Number of events 2 • 30 Days
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Investigations
Acute Heart Failure
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Investigations
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/86 • 30 Days
|
2.4%
2/84 • Number of events 2 • 30 Days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Metabolism and nutrition disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Nervous system disorders
Neuropathy Peripheral
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Nervous system disorders
Syncope
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Psychiatric disorders
Mental Status Changes
|
4.7%
4/86 • Number of events 4 • 30 Days
|
3.6%
3/84 • Number of events 3 • 30 Days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
15.1%
13/86 • Number of events 13 • 30 Days
|
10.7%
9/84 • Number of events 9 • 30 Days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Renal and urinary disorders
Urinary Retention
|
5.8%
5/86 • Number of events 5 • 30 Days
|
6.0%
5/84 • Number of events 5 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
4.7%
4/86 • Number of events 4 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
1.2%
1/86 • Number of events 2 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.3%
2/86 • Number of events 2 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/86 • Number of events 1 • 30 Days
|
2.4%
2/84 • Number of events 2 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
1.2%
1/86 • Number of events 1 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Surgical and medical procedures
Other
|
0.00%
0/86 • 30 Days
|
1.2%
1/84 • Number of events 1 • 30 Days
|
|
Surgical and medical procedures
Wound Drainage
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Vascular disorders
Hypertension
|
1.2%
1/86 • Number of events 1 • 30 Days
|
0.00%
0/84 • 30 Days
|
|
Vascular disorders
Hypotension
|
0.00%
0/86 • 30 Days
|
3.6%
3/84 • Number of events 3 • 30 Days
|
|
Vascular disorders
Other
|
1.2%
1/86 • Number of events 1 • 30 Days
|
2.4%
2/84 • Number of events 2 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place