Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status
NCT ID: NCT03407287
Last Updated: 2021-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
180 participants
OBSERVATIONAL
2018-01-08
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cardiac Catheterization
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
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.
Standard noninvasive vascular monitoring
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
Distributive shock
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
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.
Standard noninvasive vascular monitoring
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
Vasoactive and inotropic agents
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
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.
Standard noninvasive vascular monitoring
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
Congestive heart failure
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
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.
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
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
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.
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
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
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.
Standard noninvasive vascular monitoring
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
Interventions
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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
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.
Standard noninvasive vascular monitoring
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
Eligibility Criteria
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Inclusion Criteria
* Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age \>=18
* Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age \>=18
* Patients presenting to Vanderbilt University Medical Center with the diagnosis of congestive heart failure and present with symptoms of fluid overload; Age\>=18
* Patients with atrial fibrillation undergoing direct current cardioversion; Age \>=18
* Patients presenting for surgery requiring positive pressure ventilation and arterial line placement; Age \>=18
Exclusion Criteria
Distributive Shock
* 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
* 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
* 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)
* 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
* 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.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Vanderbilt University Medical Center
OTHER
Responsible Party
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Kelly Kohorst
Assistant Professor
Principal Investigators
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Kelly L. Kohorst, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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828397
Identifier Type: -
Identifier Source: org_study_id
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