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Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The overall goal of this multicenter project is to characterize the expected normal range of Peripheral IntraVenous Volume Analysis (PIVA) values during a euvolemic state, and how those ranges may be altered by comorbidities; the relationship between PIVA and intravenous volume administration during resuscitation of infected patients with presumed hypovolemia; and, the relationship between PIVA and volume decreases during diuresis in acute heart failure patients with hypervolemia.
The determination of volume status remains a clinical challenge in medicine. Patients may develop hypovolemia (too little fluids in the vascular space) due to conditions such as hemorrhage, dehydration, or infection with vascular leak. Alternatively, patients may become hypervolemic (too much fluids in the vascular space), due to conditions such as heart failure, renal failure, or iatragenic over-resuscitation all of which overwhelm the kidney's ability to regulate intravascular volume status. In clinical practice, clinicians strive to return patients to euvolemia (the "right" volume status) through the administration of intravenous fluids or diuretics which remove fluids to achieve homeostasis. While there are a number of proposed clinical exam findings (e.g. dry mucous membranes or skin turgor), measurements (e.g. central venous pressure), or laboratory tests (e.g. blood urea nitrogen), none are precise or universally accepted as reliable methodologies to assess volume status.
The goal of this study is to perform a prospective observational study on three distinct cohorts during ED presentation to assess the variability and performance of PIVA in tracking volume status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Cohort | This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia. |
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| Infection Cohort | This cohort are subjects with suspected infection, enriched to contain sepsis patients. |
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| Acute Heart Failure | This cohort will have a diagnosis of CFH who are being admitted to the hospital. These patients will be followed during their hospital course. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Intravenous Analysis (PIVA) | Procedure | Non-invasive measurement of peripheral intravenous waveform analysis (PIVA) obtained by connecting an Edwards standard transducer to a universal adaptor or stopcock on a peripheral IV |
| Measure | Description | Time Frame |
|---|---|---|
| Association between PIVA measurement and fluid status (net gain vs net loss) | Change in fluid status over the first 6 hours as measured by weight and urine output and pressure status from the Edwards transducer | Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Response to Passive leg raise | Compute the change in PIVA measurement between before and after the passive leg raise challenge within each cohort | For the euvolemic cohort, baseline to 2 hours; For hypovolemic, cohort baseline to 6 hours; for the hypervolemic cohort, baseline up to 72 hours |
| Association between PIVA and non-invasive monitoring responsiveness to passive leg raise |
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Control Cohort (Presumed Euvolemia)
Inclusion Criteria:
Exclusion Criteria:
History of any type of decreased oral intake or volume loss (e.g. diarrhea, vomiting, etc)
History of a fever
History of bleeding
Any acute illness expected to alter volume
Known or suspected pregnancy
Active irregular heart rhythm
In the opinion of the treating physician, no anticipated intravenous fluid administration
History of chronic or end stage renal disease
Liver failure
History of Acute heart failure
Presence of abnormal vital signs (90 < HR < 60; 180 < SBP < 110, respiratory rate > 20, pulse ox < 92% or need for supplemental oxygen, 99.0 < temperature < 96).
2 additional group will be included in this euvolemic group
Non-elderly patients (age < 50 year) without any comorbid illnesses and
Age >65
Diabetes on medications
Hypertension on medications
Vascular disease defined by history of peripheral vascular disease, stroke, MI
Note: patients that receive >250 cc of IVF will be excluded from analysis.
Infection Cohort (Presumed Hypovolemia)
Inclusion Criteria:
Exclusion Criteria:
Acute Heart Failure (Hypervolemic cohort)
Inclusion Criteria:
Exclusion Criteria:
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Presumed Euvolemia cohort: This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia.
Presumed Hypovolemia cohort: This is a cohort of patients with suspected infection and enriched with categories of sepsis patients.
Hypervolemic cohort: This is a cohort of patients with a diagnosis of Congestive Heart Failure (CHF) who are being admitted to the hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Medical Center | Boston | Massachusetts | 02215 | United States | ||
| St. Vincent Hospital |
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| Non-invasive fluid response measure | Procedure | To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration. |
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| Passive leg raise (PLR) | Diagnostic Test | Test to predict cardiac output and fluid responsiveness |
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Compare change in PIVA measurements to non-invasive monitoring measurements before and after passive leg raise and before and after fluid boluses |
| Baseline up to 72 hours |
| Worcester |
| Massachusetts |
| 01608 |
| United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D007239 | Infections |
| D004487 | Edema |
| D020896 | Hypovolemia |
| D012772 | Shock, Septic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012769 | Shock |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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