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Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPI Arm | Experimental | AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. |
|
| Non-HPI arm | Placebo Comparator | Non-protocolized standard of care management per clinician and provider judgement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcumenTM HPI Software Feature | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications. | A composite of 30-day moderate-to-severe perfusion related postoperative complications. | From post non-cardiac surgery to 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Northwestern University |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2022 |
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|
| Non-protocolized Standard of Care | Other | Non-protocolized standard of care to treat subjects |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Michigan Medical Health System | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 97239 | United States |
| Oregon Health & Science University | Portland | Oregon | 997239 | United States |
| UT Southwestern | Dallas | Texas | 75235 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Non-HPI Arm |
Non-protocolized standard of care management per clinician and provider judgement |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-HPI Arm | Non-protocolized standard of care management per clinician and provider judgement |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications. | A composite of 30-day moderate-to-severe perfusion related postoperative complications. | Posted | Number | participants with post-op complications | From post non-cardiac surgery to 30 days. |
|
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30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 187 | 48 | 187 | 19 | 187 |
| EG001 | Non-HPI Arm | Non-protocolized standard of care management per clinician and provider judgement | 1 | 182 | 38 | 182 | 21 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain Lower | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Ileus Paralytic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired Gastric Emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intra-Abdominal Fluid Collection | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melena | Gastrointestinal disorders | Systematic Assessment |
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| Unknown Cause Of Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Obstruction Gastric | Gastrointestinal disorders | Systematic Assessment |
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| Pneumatosis Intestinalis | Gastrointestinal disorders | Systematic Assessment |
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| Unknown Cause Of Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Other | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Other | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal Infection | Infections and infestations | Systematic Assessment |
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| Abscess | Infections and infestations | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Clostridium Difficile Colitis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Wound Infection | Infections and infestations | Systematic Assessment |
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| Viral Infection | Infections and infestations | Systematic Assessment |
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| Other | Infections and infestations | Systematic Assessment |
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| Mental Status Changes Postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other | Injury, poisoning and procedural complications | Systematic Assessment |
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| Troponin Increased | Investigations | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Lactic Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Transient Ischemic Attack (TIA) | Nervous system disorders | Systematic Assessment |
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| Other | Nervous system disorders | Systematic Assessment |
| ||
| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Other | Renal and urinary disorders | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abdominal Cavity Drainage | Surgical and medical procedures | Systematic Assessment |
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| Other | Surgical and medical procedures | Systematic Assessment |
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| Distributive Shock | Vascular disorders | Systematic Assessment |
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| Shock Hemorrhagic | Vascular disorders | Systematic Assessment |
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| Other | Vascular disorders | Systematic Assessment |
| ||
| Other | Immune system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Troponin Increased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Edwards Lifesciences | 888.713.1564 | CC_Clinical_Affairs@edwards.com |
| Dec 19, 2023 |
| Prot_SAP_000.pdf |
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| Male |
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| American Indian or Alaska Native |
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| Asian |
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| Declined to identify |
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| White |
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| Other |
|