Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients

Conditions
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Infection, Hypervolemia, Hypovolemia, Septic Shock, Acute Heart Failure, Congestive Heart Failure

Intervention / Treatment
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* Procedure: Peripheral Intravenous Analysis (PIVA)
* Procedure: Non-invasive fluid response measure
* Diagnostic Test: Passive leg raise (PLR)


Participation Criteria
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Eligibility Criteria
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Control Cohort (Presumed Euvolemia) Inclusion Criteria: Age > 18 years old Assessed as euvolemic by treating physician 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: Age > 18 years old An accessible intravenous catheter is in place Known or suspected infection as assessed by the clinical team Intention to admit to the hospital Anticipated administration of intravenous fluids per clinical team Exclusion Criteria: Clinical exam consistent with volume overload Known or suspected pregnancy Patients with a history of chronic renal insufficiency or end-stage renal disease Patients with a history of acute heart failure Acute Heart Failure (Hypervolemic cohort) Inclusion Criteria: Age > 17 years old An accessible intravenous catheter is in place Primary clinical diagnosis of CHF Meet 2 of the three criterion: X-ray diagnosis Elevated bnp from known baseline Clinical diagnosis Received or intent to administer a diuretic agent Intent to admit to the hospital for anticipated > 24 hour period 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 Known or suspected pregnancy Active irregular heart rhythm History of dialysis dependent end stage renal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Cohort<br>This cohort is recruited to help to define what a normal PIVA value should be during a state of presumed euvolemia. | Procedure: Peripheral Intravenous Analysis (PIVA)<br>* 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<br>* Other names: PIVA;Diagnostic Test: Passive leg raise (PLR)<br>* Test to predict cardiac output and fluid responsiveness<br>* Other names: PLR;|
| Infection Cohort<br>This cohort are subjects with suspected infection, enriched to contain sepsis patients. | Procedure: Peripheral Intravenous Analysis (PIVA)<br>* 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<br>* Other names: PIVA;Procedure: Non-invasive fluid response measure<br>* To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.<br>Diagnostic Test: Passive leg raise (PLR)<br>* Test to predict cardiac output and fluid responsiveness<br>* Other names: PLR;|
| Acute Heart Failure<br>This cohort will have a diagnosis of CFH who are being admitted to the hospital. These patients will be followed during their hospital course. | Procedure: Peripheral Intravenous Analysis (PIVA)<br>* 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<br>* Other names: PIVA;Procedure: Non-invasive fluid response measure<br>* To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.<br>Diagnostic Test: Passive leg raise (PLR)<br>* Test to predict cardiac output and fluid responsiveness<br>* Other names: PLR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |