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

NCT03407287 | Terminated

• 1 other identifier: 828397
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Baseline to end of monitoring (Approximately 180 minutes)

Study Arms (6)

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

Peripheral Intravenous Analysis (PIVA) PROCEDURE

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

Atrial fibrillation; Cardiac Catheterization; Congestive heart failure; Distributive shock; Patients undergoing surgery; Vasoactive and inotropic agents

Standard of care invasive vascular monitoring PROCEDURE

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.

Atrial fibrillation; Cardiac Catheterization; Congestive heart failure; Distributive shock; Patients undergoing surgery; Vasoactive and inotropic agents

Standard noninvasive vascular monitoring PROCEDURE

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

Atrial fibrillation; Cardiac Catheterization; Congestive heart failure; Distributive shock; Patients undergoing surgery; Vasoactive and inotropic agents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age \>=18
• 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
• Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age \>=18
• 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
• Patients presenting to Vanderbilt University Medical Center with the diagnosis of congestive heart failure and present with symptoms of fluid overload; Age\>=18
• 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)
• Patients with atrial fibrillation undergoing direct current cardioversion; Age \>=18
• 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
• Patients presenting for surgery requiring positive pressure ventilation and arterial line placement; Age \>=18

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Hypotension; Shock; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases

Study Officials

• Kelly L. Kohorst, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: January 8, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)