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

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ClinicalTrials.gov Identifier: NCT03736421
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : November 9, 2018
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment
Infection Hypervolemia Hypovolemia Septic Shock Acute Heart Failure Congestive Heart Failure Procedure: Peripheral Intravenous Analysis (PIVA) Procedure: Non-invasive fluid response measure Diagnostic Test: Passive leg raise (PLR)

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.

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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

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 Name: PIVA

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

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.

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

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.

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




Primary Outcome Measures :
  1. Association between PIVA measurement and fluid status (net gain vs net loss) [ Time Frame: Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort ]
    Change in fluid status over the first 6 hours as measured by weight and urine output and pressure status from the Edwards transducer


Secondary Outcome Measures :
  1. Response to Passive leg raise [ Time Frame: For the euvolemic cohort, baseline to 2 hours; For hypovolemic, cohort baseline to 6 hours; for the hypervolemic cohort, baseline up to 72 hours ]
    Compute the change in PIVA measurement between before and after the passive leg raise challenge within each cohort

  2. Association between PIVA and non-invasive monitoring responsiveness to passive leg raise [ Time Frame: Baseline up to 72 hours ]
    Compare change in PIVA measurements to non-invasive monitoring measurements before and after passive leg raise and before and after fluid boluses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736421


Locations
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United States, Massachusetts
Beth Israel Medical Center
Boston, Massachusetts, United States, 02215
St. Vincent Hospital
Worcester, Massachusetts, United States, 01608
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Baxter Healthcare Corporation
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03736421    
Other Study ID Numbers: 2018P000494
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Emergencies
Hypovolemia
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes