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

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.

Study Overview

• Status: Suspended
• Conditions: Septic Shock; Infection; Congestive Heart Failure; Hypovolemia; Acute Heart Failure; Hypervolemia
• Intervention / Treatment: Procedure: Peripheral Intravenous Analysis (PIVA); Diagnostic test: Passive leg raise (PLR); Procedure: Non-invasive fluid response measure

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.

• Study Type: Observational
• Enrollment (Anticipated): 280

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Medical Center
    • Worcester, Massachusetts, United States, 01608
      • St. Vincent Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Presumed Euvolemia cohort: This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia.

Presumed Hypovolemia cohort: This is a cohort of patients with suspected infection and enriched with categories of sepsis patients.

Hypervolemic cohort: This is a cohort of patients with a diagnosis of Congestive Heart Failure (CHF) who are being admitted to the hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Cohort; 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); 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; Other Names: PIVA; Diagnostic test: Passive leg raise (PLR); Test to predict cardiac output and fluid responsiveness; Other Names: PLR
Infection Cohort; This cohort are subjects with suspected infection, enriched to contain sepsis patients.	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; Other Names: PIVA; Diagnostic test: Passive leg raise (PLR); Test to predict cardiac output and fluid responsiveness; Other Names: PLR; 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.
Acute Heart Failure; 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); 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; Other Names: PIVA; Diagnostic test: Passive leg raise (PLR); Test to predict cardiac output and fluid responsiveness; Other Names: PLR; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Emergencies; Hypovolemia
• Other Study ID Numbers: 2018P000494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No