Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infection
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Association between PIVA measurement and fluid status (net gain vs net loss)
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Nathan Shapiro
Associate Professor of Emergency Medicine
Beth Israel Deaconess Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Association between PIVA measurement and fluid status (net gain vs net loss)
Time Frame: Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort
Change in fluid status over the first 6 hours as measured by weight and urine output and pressure status from the Edwards transducer
Secondary Outcomes
- Response to Passive leg raise(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(Baseline up to 72 hours)