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

Septic Shock Clinical Trial

— PIVA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03736421
• Other study ID #: 2018P000494
• Status: Suspended
• Start date: November 10, 2018
• Est. completion date: April 2021

Study information

• Verified date: June 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 280
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Congestive Heart Failure
• Emergencies
• Heart Failure
• Hypervolemia
• Hypovolemia
• Infection
• Septic Shock

Intervention

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
• 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.

Diagnostic Test:
• Passive leg raise (PLR)
Test to predict cardiac output and fluid responsiveness

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	Boston	Massachusetts
United States	University of Washington	Seattle	Washington
United States	St. Vincent Hospital	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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