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| Name | Class |
|---|---|
| BMEYE BV the Netherlands | UNKNOWN |
| Edwards Lifesciences | INDUSTRY |
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This multinational registry (3 USA, 2 European centers) will capture in the ED continuous non invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients presenting with acute heart failure, stroke syndromes and systemic infection. Patients will be observed after their Emergency Department (ED) disposition to determine clinical outcomes (length of stay in the hospital, the development of any organ dysfunction, mortality and need for unscheduled medical care within the ensuing 30 days). It is anticipated that specific ED hemodynamic profiles will be predictive of better clinical outcomes than others. This information will provide the outcome data needed to design future therapeutic trials that will evaluate the effect of ED hemodynamic manipulations on overall patient management and outcomes.
The PREMIUM Registry is a multinational, prospective, observational convenience study of the ED hemodynamic profiles of patients presenting with acute CHF, stroke and systemic infections and their potential relationship with patient outcomes. Continuous hemodynamics will be measured by noninvasive means using the Nexfin device and outcomes (in hospital length of stay, the interval development of organ dysfunction and mortality or the need for unscheduled medical care within the ensuing 30 days) will be captured within the registry.
The treating ED physicians will be blinded to the hemodynamic monitoring and there will be no modification of the standard care that each patient receives. Hospital charts will be reviewed and patients/family members will be additionally called at 30 days after the hospital visit in order to collect any additional outcome data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute CHF |
| ||
| Acute Stroke Syndrome |
| ||
| Acute Systemic Infection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values) | Describe the 4 hour continuous ED hemodynamic profiles (CO, SVR, SV, DP/DT and Indexed values)of patients treated under current clinical standards with acute CHF, stroke syndromes and systemic infection. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic Profiles in acute CHF, stroke, and systemic infection | Describe the hemodynamic profiles within existing risk stratification groupings currently used for these 3 disease states. These include but are not limited to BNP and troponin values for acute CHF, infarct/bleed size in acute stroke syndromes, and WBC and procalcitonin (where applicable) and blood lactate levels in systemic infections. Determine which hemodynamic profiles measured in the ED predict clinical outcomes (mortality, end organ dysfunction, and length of stay) |
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Inclusion Criteria:
General Inclusion Criteria
Inclusion Criteria for Acute CHF
Inclusion Criteria for Acute Stroke Syndrome
Inclusion Criteria for Acute Systemic Infection
Exclusion Criteria:
General Exclusion Criteria
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Potential subjects will be screened and enrolled from the Emergency Department
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Nowak, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Receiving Hospital/Wayne State University | Detroit | Michigan | 48201 | United States | ||
| Henry Ford Hospital |
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D007239 | Infections |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 4 Hours |
| Detroit |
| Michigan |
| 48202 |
| United States |
| University LaSapienza Rome Sant'Andrea Hospital | Rome | Rome | 00189 | Italy |
| VU University Medical Centre | Amsterdam | Amsterdam | Netherlands |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |