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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03407287
Recruitment Status : Suspended (interim analysis)
First Posted : January 23, 2018
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Kelly Kohorst, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Systemic Inflammatory Response Syndrome Distributive Shock Hypotension and Shock Decompensated Congestive Heart Failure Atrial Fibrillation High Risk Non-cardiac Surgery Procedure: Peripheral Intravenous Analysis (PIVA) Procedure: Standard of care invasive vascular monitoring Procedure: Standard noninvasive vascular monitoring

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

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status:
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cardiac Catheterization Procedure: Peripheral 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

Procedure: Standard 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.

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

Distributive shock Procedure: Peripheral 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

Procedure: Standard 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.

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

Vasoactive and inotropic agents Procedure: Peripheral 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

Procedure: Standard 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.

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

Congestive heart failure Procedure: Peripheral 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

Procedure: Standard 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.

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

Atrial fibrillation
Patients with atrial fibrillation undergoing elective direct current cardioversion
Procedure: Peripheral 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

Procedure: Standard 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.

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

Patients undergoing surgery
Patients undergoing surgery requiring positive pressure ventilation and arterial line placement
Procedure: Peripheral 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

Procedure: Standard 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.

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




Primary Outcome Measures :
  1. Correlation of PIVA score to standard hemodynamic monitors [ Time Frame: Baseline to end of monitoring (Approximately 180 minutes) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll patients hospitalized at Vanderbilt University Medical Center.
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.

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): NCT03407287


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Kelly L. Kohorst, MD Vanderbilt University Medical Center
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Responsible Party: Kelly Kohorst, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03407287    
Other Study ID Numbers: 828397
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: June 4, 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Hypotension
Shock
Systemic Inflammatory Response Syndrome
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Vascular Diseases
Inflammation