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

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03407287
• Collaborator: Baxter Healthcare Corporation (Industry)
• Enrollment: 180
• Location: 1
• Actual Duration (Months): 34.8
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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	Phase
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

Study Design

• Study Type: Observational
• Actual 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: Jan 8, 2018
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Correlation of PIVA score to standard hemodynamic monitors [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

• Vanderbilt University Medical Center
• Baxter Healthcare Corporation

Investigators

• Principal Investigator: Kelly L. Kohorst, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kelly Kohorst, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03407287
• Other Study ID Numbers: 828397
• First Posted: Jan 23, 2018
• Last Update Posted: Apr 12, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Heart Failure; Atrial Fibrillation; Hypotension; Shock; Systemic Inflammatory Response Syndrome

Study Results

No Results Posted as of Apr 12, 2021