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

Terminated

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

• Registration Number: NCT03407287
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-23
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States