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

Beth Israel Lahey Health

Status

Terminated

Conditions

Infection

Hypovolemia

Acute Heart Failure

Hypervolemia

Septic Shock

Congestive Heart Failure

Treatments

Diagnostic Test: Passive leg raise (PLR)

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Non-invasive fluid response measure

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03736421

2018P000494

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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