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TerminatedNCT03407287PIVAUpdated Apr 12, 2021

Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status

An observational study in Systemic Inflammatory Response Syndrome, Distributive Shock and Hypotension and Shock, sponsored by Vanderbilt University Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-12.

Sponsored by Vanderbilt University Medical Center · Observational

Why this study was terminated
interim analysis, closed for additional product development
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to determine the effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the Peripheral Intravenous waveform Analysis (PIVA) signal.

Read the detailed description

Intravascular volume status determination remains elusive. Standard vital sign monitoring, including heart rate and blood pressure, fails to detect intravascular volume depletion and volume overload. Likewise, invasive monitoring is fraught with risk including vascular injury and central line associated infections. As such, a minimally-invasive mechanism to overcome the barriers of standard monitoring to detect volume status derangement, would be highly valuable. The goal of the study is to perform a series of observational feasibility studies in healthy and hospitalized subjects to determine effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the PIVA signal

02

Conditions studied

  • Systemic Inflammatory Response Syndrome
  • Distributive Shock
  • Hypotension and Shock
  • Decompensated Congestive Heart Failure
  • Atrial Fibrillation
  • High Risk Non-cardiac Surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will enroll patients hospitalized at Vanderbilt University Medical Center.

Eligibility criteria

Cardiac Catheterization

Inclusion criteria:

  • Patients undergoing right heart catheterization or left and right heart catheterizaton; Age >=18

Exclusion criteria:

  • Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, aortic or mitral valve disease greater than mild in severity, aortic or mitral valve replacement, active irregular heart rhythm, patients with restrictive cardiomyopathies (cardiac amyloidosis), constrictive cardiac disease (constrictive pericarditis or cardiac-tamponade), congenital heart disease other than foramen ovale, repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care. Pressors, starches, lipids, propofol, or D10 or higher running through the PIVA line.

Distributive Shock

Inclusion Criteria:

  • Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age >=18

Exclusion Criteria:

  • Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extracorporeal membrane oxygenation), ongoing ACLS, severe tricuspid regurgitation or stenosis, patient with restrictive cardiomyopathies (cardiac amyloidosis), patients receiving pulmonary vasodilators (nitric oxide, sodium nitroprusside, sildenafil), atrial fibrillation, congenital heart disease, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care.

Vasoactive and Inotropic Agents

Inclusion Criteria:

  • Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age >=18

Exclusion Criteria:

  • Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extracorporeal membrane oxygenation), ongoing ACLS, severe tricuspid regurgitation or stenosis, patient with restrictive cardiomyopathies (cardiac amyloidosis), patients receiving pulmonary vasodilators (nitric oxide, sodium nitroprusside, sildenafil), atrial fibrillation, congenital heart disease, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care.

Congestive Heart Failure

Inclusion Criteria:

  • Patients presenting to Vanderbilt University Medical Center with the diagnosis of congestive heart failure and present with symptoms of fluid overload; Age>=18

Exclusion Criteria:

  • Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, active irregular heart rhythm, patient with restrictive cardiomyopathies (cardiac amyloidosis), or constrictive cardiac disease (constrictive pericarditis or cardiac tamponade), congenital heart disease other than foramen ovale, repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care.

Atrial Fibrillation (undergoing elective direct current cardio version)

Inclusion Criteria:

  • Patients with atrial fibrillation undergoing direct current cardioversion; Age >=18

Exclusion Criteria:

  • Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, patients with restrictive cardiomyopathies (cardiac amyloidosis) or constrictive cardiac disease (constrictive pericarditis or cardiac tamponade), congenital heart disease other than foramen ovale, repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care.

Patients undergoing Surgery

Inclusion Criteria:

  • Patients presenting for surgery requiring positive pressure ventilation and arterial line placement; Age >=18

Exclusion Criteria:

  • Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, patients with restrictive cardiomyopathies (cardiac amyloidosis) or constrictive cardiac disease (constrictive pericarditis or cardiac tamponade), active irregular cardiac rhythm, congenital heart disease other than foramen ovale , repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, patients with known psychiatric or neurological disease who are unable to consent, or any other medical condition which, in the opinion of the investigator, would place the patient at undue risk from participation in the trial. Patients who do not have a functional peripheral IV as part of standard care.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • Cardiac Catheterization

    Procedure: Peripheral Intravenous Analysis (PIVA) · Procedure: Standard of care invasive vascular monitoring · Procedure: Standard noninvasive vascular monitoring

  • Distributive shock

    Procedure: Peripheral Intravenous Analysis (PIVA) · Procedure: Standard of care invasive vascular monitoring · Procedure: Standard noninvasive vascular monitoring

  • Vasoactive and inotropic agents

    Procedure: Peripheral Intravenous Analysis (PIVA) · Procedure: Standard of care invasive vascular monitoring · Procedure: Standard noninvasive vascular monitoring

  • Congestive heart failure

    Procedure: Peripheral Intravenous Analysis (PIVA) · Procedure: Standard of care invasive vascular monitoring · Procedure: Standard noninvasive vascular monitoring

  • Atrial fibrillation

    Patients with atrial fibrillation undergoing elective direct current cardioversion

    Procedure: Peripheral Intravenous Analysis (PIVA) · Procedure: Standard of care invasive vascular monitoring · Procedure: Standard noninvasive vascular monitoring

  • Patients undergoing surgery

    Patients undergoing surgery requiring positive pressure ventilation and arterial line placement

    Procedure: Peripheral Intravenous Analysis (PIVA) · Procedure: Standard of care invasive vascular monitoring · Procedure: Standard noninvasive vascular monitoring

Interventions

  • ProcedurePeripheral Intravenous Analysis (PIVA)

    Non-invasive measurement of peripheral venous waveform analysis (PIVA) obtained by connecting a standard transducer (AD Instruments, Colorado Springs, Co) to a universal adaptor or stopcock on a peripheral IV

  • ProcedureStandard of care invasive vascular monitoring

    Standard of care invasive monitoring in the intensive care settings with central venous catheters, pulmonary artery catheters, or trans-esophageal echocardiography for determining volume status.

  • ProcedureStandard noninvasive vascular monitoring

    Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.

05

What researchers measure

Primary outcomes

  1. Correlation of PIVA score to standard hemodynamic monitors

    Peripheral intravenous waveform analysis score is used to detect intravascular volume status. The scale ranges from 2-40 and is interpreted as a surrogate for pulmonary capillary wedge pressure. The normal scale range is 6-12. A PIVA score of 2 indicates a low intravascular volume and 40 indicates a high intravascular volume.

    Time frame: Baseline to end of monitoring (Approximately 180 minutes)

06

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407287
Lead sponsor
Vanderbilt University Medical Center
Collaborators
Baxter Healthcare Corporation
Responsible party
Kelly Kohorst (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Jan 23, 2018
Start date
Jan 8, 2018
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020
Last update
Apr 12, 2021

Study contacts

Kelly L. Kohorst, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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