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

Stopped early

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

In brief

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.

Key facts

Study ID

NCT03736421

Run by

Beth Israel Deaconess Medical Center

People needed

50

Starts

2018-11-10

Expected to finish

2021-10-01

Last updated by the study team

2024-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age > 18 years old
• Assessed as "euvolemic" by treating physician

You may not qualify if…

• 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

Where it is running

• Beth Israel Medical Center — Boston, Massachusetts, United States
• St. Vincent Hospital — Worcester, Massachusetts, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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