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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

Tracking Information
First Submitted Date January 16, 2018
First Posted Date January 23, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date January 8, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2019)
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.
Original Primary Outcome Measures
 (submitted: January 22, 2018)
Correlation of PIVA score to standard hemodynamic monitors [ Time Frame: Baseline to end of monitoring (Approximately 180 minutes) ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status
Official Title Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status:
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study will enroll patients hospitalized at Vanderbilt University Medical Center.
Condition
  • Systemic Inflammatory Response Syndrome
  • Distributive Shock
  • Hypotension and Shock
  • Decompensated Congestive Heart Failure
  • Atrial Fibrillation
  • High Risk Non-cardiac Surgery
Intervention
  • 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.
Study Groups/Cohorts
  • Cardiac Catheterization
    Interventions:
    • Procedure: Peripheral Intravenous Analysis (PIVA)
    • Procedure: Standard of care invasive vascular monitoring
    • Procedure: Standard noninvasive vascular monitoring
  • Distributive shock
    Interventions:
    • Procedure: Peripheral Intravenous Analysis (PIVA)
    • Procedure: Standard of care invasive vascular monitoring
    • Procedure: Standard noninvasive vascular monitoring
  • Vasoactive and inotropic agents
    Interventions:
    • Procedure: Peripheral Intravenous Analysis (PIVA)
    • Procedure: Standard of care invasive vascular monitoring
    • Procedure: Standard noninvasive vascular monitoring
  • Congestive heart failure
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Procedure: Peripheral Intravenous Analysis (PIVA)
    • Procedure: Standard of care invasive vascular monitoring
    • Procedure: Standard noninvasive vascular monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: January 22, 2018)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03407287
Other Study ID Numbers 828397
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kelly Kohorst, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Baxter Healthcare Corporation
Investigators
Principal Investigator: Kelly L. Kohorst, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date June 2020