NCT03736421

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infection
• Hypervolemia
• Hypovolemia
• Septic Shock
• Acute Heart Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Peripheral Intravenous Analysis (PIVA)	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
PROCEDURE	Non-invasive fluid response measure	To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.
DIAGNOSTIC_TEST	Passive leg raise (PLR)	Test to predict cardiac output and fluid responsiveness

Timeline

• Start date: 2018-11-10
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2018-11-09
• Last updated: 2024-10-29

Locations

3 sites across 1 country: United States