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

NCT ID: NCT03736421

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-10
• Study Completion Date: 2021-10-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Cohort

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

Peripheral Intravenous Analysis (PIVA)

Intervention Type: 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

Passive leg raise (PLR)

Intervention Type: DIAGNOSTIC_TEST

Test to predict cardiac output and fluid responsiveness

Infection Cohort

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

Peripheral Intravenous Analysis (PIVA)

Intervention Type: 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

Non-invasive fluid response measure

Intervention Type: PROCEDURE

To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.

Passive leg raise (PLR)

Intervention Type: DIAGNOSTIC_TEST

Test to predict cardiac output and fluid responsiveness

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.

Peripheral Intravenous Analysis (PIVA)

Intervention Type: 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

Non-invasive fluid response measure

Intervention Type: PROCEDURE

To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.

Passive leg raise (PLR)

Intervention Type: DIAGNOSTIC_TEST

Test to predict cardiac output and fluid responsiveness

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Passive leg raise (PLR)

Test to predict cardiac output and fluid responsiveness

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PIVA; PLR

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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
• 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)

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nathan Shapiro

Associate Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Medical Center

Boston, Massachusetts, United States

St. Vincent Hospital

Worcester, Massachusetts, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

2018P000494

Identifier Type: -

Identifier Source: org_study_id