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

NCT03736421 | Terminated DMC

• 1 other identifier: 2018P000494
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

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); Diagnostic Test: Passive leg raise (PLR)

Infection Cohort

This cohort are subjects with suspected infection, enriched to contain sepsis patients.

Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Non-invasive fluid response measure; Diagnostic Test: Passive leg raise (PLR)

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); Procedure: Non-invasive fluid response measure; Diagnostic Test: Passive leg raise (PLR)

Interventions

Peripheral Intravenous Analysis (PIVA) PROCEDURE

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

Also known as: PIVA

Acute Heart Failure; Control Cohort; Infection Cohort

Non-invasive fluid response measure PROCEDURE

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; Infection Cohort

Passive leg raise (PLR) DIAGNOSTIC_TEST

Test to predict cardiac output and fluid responsiveness

Also known as: PLR

Acute Heart Failure; Control Cohort; Infection Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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).
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (3)

Beth Israel Medical Center

Boston, Massachusetts, 02215, United States

Location

St. Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Infections; Edema; Hypovolemia; Shock, Septic; Heart Failure

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 9, 2018
• Study Start: November 10, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)